Catalog Number UNK_JR |
Device Problems
Unstable (1667); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
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Patient Problems
Loss of Range of Motion (2032); Injury (2348); Joint Dislocation (2374)
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Event Date 10/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that patient's left hip was revised after multiple dislocations due to instability and impingement.Head and liner were revised to include a constrained liner.
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Manufacturer Narrative
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Adding investigation conclusion reported event: an event regarding multiple dislocations due to instability and impingement involving an unknown head was reported.Head impingement was confirmed through clinician review of the medical records provided.Method & results: product evaluation and results: not performed as no product was returned for evaluation.Clinician review: a review of the provided medical records by a clinical consultant indicated: an adverse combination of procedure related factors including cup malposition with additional inappropriate use of an offset liner plus skirted femoral head with patient-related factors including reduced soft tissue stability of the hip due to previous surgeries and possibly age-related muscular atrophy around the hip has contributed to instability with hip impingement and recurrent dislocation requiring a second revision surgery in 2018 after a previous hip revision in 2015 failed to solve this same problem of instability.Product history review: not performed as no lot information was provided.Complaint history review: not performed as no lot information was provided.Conclusion: a review of the provided medical records by a clinical consultant indicated: an adverse combination of procedure-related factors including cup malposition with additional inappropriate use of an offset liner plus skirted femoral head with patient-related factors including reduced soft tissue stability of the hip due to previous surgeries and possibly age-related muscular atrophy around the hip has contributed to instability with hip impingement and recurrent dislocation requiring a second revision surgery in 2018 after a previous hip revision in 2015 failed to solve this same problem of instability.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that patient's left hip was revised after multiple dislocations due to instability and impingement.Head and liner were revised to include a constrained liner.
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Search Alerts/Recalls
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