Catalog Number UNK HIP ACETABULAR CUP |
Device Problems
Off-Label Use (1494); Naturally Worn (2988)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Necrosis (1971); Sepsis (2067); Osteolysis (2377); Test Result (2695); No Code Available (3191)
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Event Date 11/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Asr medical records received.After review of medical records, the patient was revised to address a failed right total hip arthroplasty due to metallosis, elevated metal ions with sepsis.Intraoperatively, approximately 100 ml of abundant cloudy fluid poured out from the capsule.The capsule was consistent with adverse reaction to metal debris.The femoral component was stable but there was a necrotic, osteolytic lesion.The patient was noted to be about 4mm short preoperatively.The cup was noted to have 59 degrees of inclination with significant anteversion.However, the surgeon did not consider the cup to be malpositioned given the patient's severe spinopelvic mal-alignment.The surgeon elected to retain the asr xl cup and the stem.Doi: (b)(6) 2009.Dor: (b)(6) 2018.(right hip).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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