Model Number 1218-87-354 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Synovitis (2094); Osteolysis (2377); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/30/2020 |
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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Clinical notification received for revision of right total hip to address osteolysis.Date of implantation: (b)(6) 2010; date of revision: (b)(6) 2020; (right hip).Treatment: revision of head and liner.
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Event Description
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On (b)(6) 2020, the patient underwent a right hip revision to address osteolysis, elevated metal levels (values not given), early pseudotumor, and limb asymmetry.The surgeon noted synovitis and reactive change in the soft tissue, as well as gray discoloration consistent with metal debris.The trunnion was cleaned with a scratch pad to clear all corrosion.Massive osteolysis was noted around the femur, however, the femur was very well intact and retained along with the cup.The head and liner were revised.There were no indicated intra-operative complications.
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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: b5 and h6 (patient,device).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the blood heavy metal increase.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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Examination of the provided x-ray images finds nothing indicative of a product problem.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: a complaint database search and/or device manufacturing (dhr) reviews will not be performed.(b)(4), it has been determined that should related reports be identified a dhr review is not required.H10 additional narrative: added: b1 (product problem).
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Search Alerts/Recalls
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