Catalog Number UNK HIP ACETABULAR LINER |
Device Problems
Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Injury (2348); Joint Dislocation (2374)
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Event Date 07/19/2017 |
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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Pinnacle claim letter and medical record received.Claim letter alleges extreme high levels of metal in the blood in which a metal debris was found on the patient's hip during revision surgery.It was also indicated that the plaintiff suffered from injuries and intend to seek damages.After review of medical records for reportability, patient was revised to address dislocated right hip.It was stated that patient had undergone a revision hip replacement in the day before.In the post-operative pacu x-ray of the hip was discarded anteriorly.Liner was elected to converted the hip to constrained liner.Doi: (b)(6) 2017; dor: (b)(6) 2017; right hip (pinnacle).
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Manufacturer Narrative
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(b)(4).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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Manufacturer Narrative
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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 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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Search Alerts/Recalls
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