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Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Device Dislodged or Dislocated (2923); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Muscular Rigidity (1968); Pain (1994); Distress (2329); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
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Event Date 09/12/2018 |
Event Type
Injury
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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.
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Event Description
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The patient was revised due to pain.
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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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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 will be filed as appropriate.
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Event Description
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Pinnacle litigation records received alleging implant dislocation, discomfort, pain, stiffness, inability to weight bear, pseudotumor development, loss of motion, soft tissue damage, muscle damage, injury and emotional distress.
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Manufacturer Narrative
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Product complaint # (b)(4).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.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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Search Alerts/Recalls
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