The literature article entitled, "the odyssey of porous-coated fixation" written by charles a.Engh, sr., md and robert h.Hopper, jr., phd published by the journal of arthroplasty vol.17 no.4 suppl.1 2002 was reviewed.The article's purpose was to review experience with femoral fixation using proximally and extensively porous-coated variants of the depuy stems.Data was compiled from 2,854 stems implanted between 1977 and 1998.The article does not identify which specific product platforms are associated with the adverse events.The article does not provide adequate information to determine accurate quantities.Depuy products utilized: non-modular and modular aml stems, prodigy stems, solution stems, metal femoral heads, cup (platform not identified), poly liner adverse events: revisions for the following reasons: loose stem (with evidence of migration), infection, pain, implant stem fracture, recurrent dislocation, leg-length inequality, periprosthetic femoral fracture (during immediate postoperative period), loose cup, and poly liner exchange for wear (associated with osteolysis).
|
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|