Model Number 1217-12-048 |
Device Problems
Device Dislodged or Dislocated (2923); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/06/2016 |
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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Surgeon is reporting a disassociation of inlay from cup.Right side affected.Doi: (b)(6) 2015, dor: (b)(6) 2016 - revision of inlay.
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Event Description
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Medical records received and reviewed: 2011: patient underwent a left hip replacement.Manufacturer of the implants is unknown.(b)(6) 2015: patient underwent a right hip replacement with depuy implants due to osteoarthritis.(b)(6) 2015: radiology films indicated normal positioning of the right hip with no loosening.(b)(6) 2016: radiology films for the right hip indicated the stem was slightly collapsed with a lytic area under the shoulder of the stem.Cup loosening could also not be ruled out.(b)(6) 2016: patient underwent a revision after experiencing grinding/squeaking and dislocation with suspected inlay disassociation.Patient was noted to be pain and symptom free.X-ray showed decentralized femoral head.Revision operative note indicated synovitis, trochanteric bursitis, and metallosis.Dislocation and disassociation were confirmed.There were signs of implant impingement, but it was noted to be secondary to the grinding after the disassociation.The femoral head and acetabular liner were revised.There was no indication of cup loosening, stem migration, or osteolysis as indicated on the (b)(6) 2016 radiology films.(b)(6) 2016: radiology films indicated normal positioning of the right hip with no loosening.(b)(6) 2016: patient reports a clicking sound.Radiology films indicated normal positioning of the right hip with no loosening.(b)(6): 2019: patient reports right hip pain.No reported product issue via x-ray.No medical intervention noted.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b5, b7, d6a, d10 and h6 (clinical and device codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2b, d4 (lot number, catalog, udi), g4 and h4.
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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 device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.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 device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.Device history review : the device manufacturing record (mre) has been reviewed.There were no related deviations, anomalies or non-conformances identified.
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Search Alerts/Recalls
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