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Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration

¹ 11631 S.W. 2nd Street, Pembroke Pines, FL 33025
² Centers for Disease Control, MS-A34 (M.A.M.), MS-E08 (J.A.P.), and MS-G25 (T.R.C.), Atlanta GA 30329-4018
³ 2045 Silverwood Drive, Newtown, PA 18940
⁴ Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852. E-mail address for M.M. Braun: braunm{at}cber.fda.gov
⁵ Johns Hopkins University, 601 North Caroline Street, Baltimore, MD 21287

Investigation performed at the Center for Biologics Evaluations and Research, Food and Drug Administration, Rockville, Maryland

NOTE: The authors thank Dr. Susan Leibenhaut for her contribution in the critical revision of the manuscript.

The authors did not receive grants or outside funding in support of their research for or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

Methods: We reviewed adverse event reports that had been submitted to the Food and Drug Administration's MedWatch system for information on demographic characteristics, adverse events, and surgical revisions. Adverse events were categorized into sixteen non-mutually exclusive groups. Five categories were used to classify reoperations. Food and Drug Administration regulations require manufacturers to report adverse events; however, reporting by clinicians and others is voluntary. Therefore, adverse event reporting is likely to underestimate the number of event occurrences. Adverse events may be either causally or coincidentally related to the product.

Results: A total of 497 adverse events among 294 patients receiving Carticel were reported. The median interval from Carticel implantation to the diagnosis of an adverse event was 240 days (range, one to 2105 days). The median age of the patients was thirty-eight years, and 63% of the patients were male. Of the 270 events for which the anatomic site was noted, 258 (96%) involved the femoral condyles. More than one adverse event was reported for 135 patients (46%). The most commonly reported events were graft failure (seventy-three patients; 25%), delamination (sixty-five patients; 22%), and tissue hypertrophy (fifty-two patients; 18%). In addition, eighteen surgical site infections were reported, including eleven joint and seven soft-tissue infections. Surgical revision subsequent to Carticel implantation was mentioned in the records for 273 patients (93%). The reasons for the 389 revision procedures included graft-related problems (187 procedures; 48.1%), periarticular soft-tissue problems (ninety-seven procedures; 24.9%), and intra-articular problems (sixty-three procedures; 16.2%). Eight patients had a total knee replacement. Based on the manufacturer's reported distribution of 7500 Carticel lots between 1995 and 2002, 285 patients (3.8%) had an adverse event that was reported to the Food and Drug Administration.

Conclusions: The most common adverse events reported in association with the Carticel technique involved graft failure, delamination, and tissue hypertrophy.

Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.

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