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      Coordinating retrieval and register studies improves postmarket surveillance.

      Clinical Orthopaedics and Related Research

      Humans, Hip Prosthesis, Osteolysis, complications, Product Surveillance, Postmarketing, Prosthesis Failure, etiology, Registries, Device Removal, Equipment Failure Analysis

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          The relative risk of revision of the Titan(®) femoral stem due to aseptic loosening increased after 2000; however, the reasons for this have not been established. A retrieval analysis was initiated with the aim of delineating the failure mechanism. We asked whether aseptic loosening in stems after 2000 was associated with (1) appearance of osteolytic lesions, (2) wear particle exposure, (3) stem damage, or (4) changes to the implant or surgical instrumentation. Femoral stems, cement, tissue, and radiographs were collected from 28 patients. We assessed the development of osteolytic lesions in 17 patients. Exposure to wear particles was quantified in 18 patients. Stem damage was assessed in 15 patients. We observed differences in the implants by examination of 24 retrieved stems. Information concerning changes to instrumentation was requested from the manufacturer. We found osteolysis in all patients receiving implants after 2000, which was associated with a median dose of cement and stem particles of 14,726/mm(2). Abrasion covered 59% of the surface of stems implanted from 1999. We identified geometric changes to the stem, the percent weight of aluminum in the stem's oxide layer decreased from 25% to 14% after 1997 and the rasp used to prepare the femoral cavity changed to a broach in 1999. Stems implanted from 2000 failed through osteolysis induced by particles released from the cement and implant. Changes to implant geometry, surface oxide layer, and surgical tools occurred in the same time frame as the reduction in survivorship.

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