Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Pain (1994)
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Event Date 05/31/2016 |
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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Complaint description: patient revised to address pain and slightly vertical cup.Explantation of the liner was not successful./ | investigation method: examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.A photograph of an x-ray was provided and reviewed.Nothing indicative of device non-conformance noted.No implant disassociation or implant fracture noted.The investigation can draw no conclusion regarding the reported event with the information available.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event./ | investigation summary: patient revised to address pain and slightly vertical cup.Explantation of the liner was not successful.Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.A photograph of an x-ray was provided and reviewed.Nothing indicative of device non-conformance noted.The investigation can draw no conclusion regarding the reported event with the information available.Based on the inability to determine root cause, the need for corrective action has not been indicated.
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Event Description
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Pinnacle pfs and medical records received.There is no new allegation for the left side.Shall there be new information received, this complaint will be updated.Added medical history and patient weight.
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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.
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Search Alerts/Recalls
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