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BI 108- Spring 2007

Major Recalls of Organ Replacement Devices

 

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Sulzer Total Hip Replacement Recall

 

Background

Each year approximately 310,000 Americans undergo partial or full hip replacement surgery.  This population of patients most commonly consists of those above the age of 65 who suffer from osteoarthritis.  Other indications for replacement include rheumatoid arthritis and certain hip fractures.  As the population of the United States continues to age, the need for such a surgery will continue to increase as well.

Acetabular component of hip implant

Figure 1: Acetabular component of hip implant [1]

The surgery itself involves replacing the natural hip with a mechanical replacement made up of a ball-and-socket joint.  The metal “ball” is mounted on a stem which fits into the femur.  The “socket” is modeled after the acetabulum which is the concave surface of the pelvis where the head of the femur meets the pelvis.  The mechanical socket is a titanium shell lined with polyethylene.  A typical hip replacement surgery costs the patient between $20,000 and $50,000 [2].

Diagram of Hip Implant

Figure 2: Diagram of Hip Implant [3]

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Device Failure and Recall

In 2000, many patients complained of increasing pain during their recovery from hip replacements of implants made by Sulzer Orthopedics of Austin, Texas (a subsidiary of Sulzer Medica Ltd.).  In addition, several surgeons reported cases of early failure which led to a thorough investigation by the company.  On December 8, 2000, Sulzer recalled 31,000 Inter-Op acetabular shells, 17,500 of which had already been implanted [4].  Sulzer, which controlled about 11 percent of the hip-replacement market, started producing these shells beginning in 1997 when the company decided to bring the manufacturing process “in-house.” [5]  The failure arose from an attempt to cut costs which resulted in leaving a residue of four possible machining oils made by Mobil Oil Co. on the backside of the shell.  This residue inhibited the bone growth necessary for bonding between the shell and pelvic bone.  This in effect, caused the shell to loosen, scar tissue to form, and in some cases additional bone loss.  Patients implanted with this defected product experienced pain in the groin and inner thigh, pain when rising from a seated position, and weight-bearing pain.  Due to these severe symptoms, many needed revision surgery.   As of February 2005, 2,353 Sulzer implants have been removed [6].

Acetabulum showing during revision surgery

Figure 3: Acetabulum showing during revision surgery [7]

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Resolutions

In the class action lawsuit, Sulzer companies agreed on a $1 billion settlement approved on May 8, 2002 by Judge Kathleen O’Malley[8].  As part of this sum, Sulzer agreed to pay patients who had undergone a revision to their implant $160,000 plus $1,600 to derivative claimants (spouses, significant others).  In addition, $120,000 was paid to patients who needed a new implant but due to medical reasons were unable to get one. Sulzer also paid those who were implanted with a recalled hip but did not need a revision surgery a sum of $1,000 plus $250 to the derivative claimants [9].

Soon after, on May 30, 2002, Sulzer Medica announced that it would operate under the name of Centerpulse Orthopedics AG.

In 2005, Dr. Thomas J Blumenfeld and Dr William L Bargar performed a study on 37 patients (40 hips) to address the clinical and radiographic results from the recalled hip implants [10].  They assessed whether clinical failure was present based on patient pain or inability to walk.  In addition, radiographs were obtained in order to visualize the implants’ loosening.  Of these hips, 13 of them needed revision because the acetabular components shifted drastically enough to cause severe pain.  Although this failure rate of 32.5% is unacceptable, it does show that not all the patients implanted with recalled hips needed revision surgery.  Blumenfeld and Bargar believe that this could be for two reasons.  For one, not all of the components manufactured were defective.  Another possibility was that failure could be due to the quality and amount of oil left on the shells.  Regardless, Sulzer unsuccessfully examined their own manufacturing techniques which resulted in many failed implants.

Discograph of definitely loose acetabular component

Figure 4: Discograph of definitely loose acetabular component [11]

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References

[1]  Lefevre, Greg. “Hip Replacement Patients May Face More Surgery” www.archives.cnn.com/2001/HEALTH/01/17/hip.replacement  17 January, 2001. 

[2]  Safety Forum. “Sulzer Hip Replacements” www.safetyforum.com/sulzerhip 15 April, 2007.

[3]  Safety Forum. “Sulzer Hip Replacements” www.safetyforum.com/sulzerhip 15 April, 2007.

[4]  Colliver, Vitoria. “Physicians Race to Replace Hip Implants” http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/02/18/BU138873.DTL 18 February, 2001.

[5]  Safety Forum. “Sulzer Hip Replacements” www.safetyforum.com/sulzerhip 15 April, 2007.

[6]  Blumenfeld, Thomas J. and Bargar, William L.  “Early Aseptic Loosening of a Modern Acetabular Component Secondary to a Change in Manufacturing” The Journal of Arthroplasty, 5 August, 2006, 689-695.

[7]  Blumenfeld, Thomas J. and Bargar, William L.  “Early Aseptic Loosening of a Modern Acetabular Component Secondary to a Change in Manufacturing” The Journal of Arthroplasty, 5 August, 2006, 689-695.

[8]  O’Malley, Kathleen M. Order of Trial Court Approval, http://www.sulzerimplantsettlement.com/tca.htm  8 May, 2002.

[9]  Bowen, Donna. “Drugs, Devices and Preemption” http://www.slackdavis.com/pdfs/DrugsDevices.pdf 26 September, 2002.

[10]  Blumenfeld, Thomas J. and Bargar, William L.  “Early Aseptic Loosening of a Modern Acetabular Component Secondary to a Change in Manufacturing” The Journal of Arthroplasty, 5 August, 2006, 689-695.

[11]  Blumenfeld, Thomas J. and Bargar, William L.  “Early Aseptic Loosening of a Modern Acetabular Component Secondary to a Change in Manufacturing” The Journal of Arthroplasty, 5 August, 2006, 689-695.

 

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Last Updated: April 30, 2007