Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Injury (2348); Deformity/ Disfigurement (2360); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); 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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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Claim letter received.Claim letter alleges pain in the groin, stiffness, cobalt and chrome metal ion poisoning, bone tissue damage, and the growth of a pseudotumor at the site of the implant, swelling, limited mobility, osteolytic lesion, osteolysis, among other problems.Doi: 2003; dor: (b)(6) 2017; right hip.
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Manufacturer Narrative
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(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 code(s) was not provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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In addition to what was previously reported, litigation also alleges disfigurement, mental anguish, suffereing, and clicking sound.Doi: 2003; dor:(b)(4) 2017; right hip.
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Manufacturer Narrative
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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, post market surveillance, 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.
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Manufacturer Narrative
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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, post market surveillance, 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.
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Event Description
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In addition to what previously alleged, ppf alleges metal wear before first revision.Added date of implant, product experience code.Corrected patient identifier.Doi: (b)(6) 2004.Dor: (b)(6) 2017.(right 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 caused or contributed to the potential event described in this report.Udi: (b)(4).
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Search Alerts/Recalls
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