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Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Degraded (1153)
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Patient Problems
Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 02/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Pfs and medical records received.Pfs alleges pain, impaired mobility, and elevated metal ions.After review of medical records, patient was revised to address right hip pain and clicking of right hip, status post right total hip arthroplasty, metal-on-metal hip replacement, dislodgement of metal liner with significant metallosis and corrosion of the femoral neck taper.Revision notes stated of extensive scar tissue on the tensor fascia lata.A large amount of effusion, slightly turbid, which looked consistent with underlying metallosis was noticed when the short external rotator and the capsule were elevated as a flap.There was extensive metallosis all around the hip joint and the capsule.The trunnion has an extensive corrosion which was cleaned thoroughly.When the socket was exposed, it was noticed that the underlying metal liner of the socket got dislodged, and osteolysis was found towards the back of the socket.Doi: (b)(6) 2004; dor: (b)(6) 2017; (right hip).Patient is bilateral.See (b)(4) for left hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # = > (b)(4).Investigation summary = > 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 number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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