Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); No Code Available (3191)
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Event Date 11/21/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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"the literature article entitled, ""femoral stem fracture and in vivo corrosion of retrieved modular femoral hips"" written by j.Caitlin huot carlson, ms, douglas w.Van citters, phd, john h.Currier, ms, amber m.Bryant, be, michael b.Mayor, md, and john p.Collier, de published by the journal of arthroplasty vol.27 no.7 2012 accepted by publisher 21 november 2011 was reviewed.The article's purpose was to report on retrieved modular femoral stems and inspect for corrosion.All stems were srom stems.Article reports that femoral heads were ceramic or metal.Liners may have been metal, ceramic or poly and the cups are not identified but assumed to be depuy implants.Inspection revealed that most stems had some degree of 'fretting' or corrosion at modular junctions including stem and sleeve interface or (and) stem and head junction.However the article does not quantify the findings to modular junction locations in order to determine accurate quantities.Table 1 provided further detail of reasons stems were explanted.Each case is captured individually for reason of revision and any information provided in the table and article in linked complaints." this complaint captures case no 58 that received revision when the stem was explanted at 5 months post initial implant for reason of dislocation.The patient¿s age was 60 and gender identity male.
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction (b)(4) appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No product contribution was identified and no information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
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Search Alerts/Recalls
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