Catalog Number 999800760 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Osteolysis (2377); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Insufficient Information (4580)
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Event Date 12/01/2020 |
Event Type
Injury
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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.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.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 litigation records received.Records alleges injury, economic loss, loss of services and loss of consortium.Doi: (b)(6) 2007 dor: (b)(6) 2020 left hip.
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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.Udi (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Failed left total hip replacement secondary to adverse local tissue reaction, associated with metal-on-metal large head total hip replacement.There was a relatively large contained lytic lesion in the inferior aspect of the acetabulum.Operative notes reported that there was a significant taper corrosion on the taper which extended beyond the neck of the femoral component, that is, the corrosion extended outside of the taper.A lytic lesion which had been debrided.Operative findings indicated that there was a moderate amount of fluid in the hip joint.There was also a pseudotumor component which was solid.There was a large contained lytic defect in the inferior half of the acetabulum.The soft tissues were in poor condition.The gluteus medius tendon looked good, but the minimus tendon was actually degenerative and partially avulsed.Doi: (b)(6) 2007 dor: (b)(6) 2020 left 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.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.Device history lot : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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