Model Number 1365-51-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Nerve Damage (1979); Pain (1994); Unspecified Tissue Injury (4559)
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Event Date 07/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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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After review of medical records patient was revised was due to periprosthetic acetabular fracture, heterotopic ossification, neurolysis of sciatic nerve, pain and complex wound of hip.Operative notes indicated acetabular component was grossly loose, screw was broken and it had migrated medially.Severe bone loss and complete discontinuity of the anterior-posterior columns.Doi: (b)(6) 2010; dor: (b)(6) 2015; 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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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