Catalog Number 157011150 |
Device Problem
Degraded (1153)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 10/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).E3 initial reporter occupation: lawyer.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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Asr litigation complaint received ad 14 mar 2024.Patient underwent surgery with no reason for revision.Additional event information: update ad 4 apr 2024 plaintiff disclosure form and medical records received.After review of medical records patient was revised was due to failed right total hip arthroplasty.Operative notes indicated increasing pain, cobalt and chromium level slowly rise, mri scan shows large amount of synovitis.Upon incision a large amount of fluid was encountered, there was some corrosion at the base of the morse taper, but was able to remove this without difficulty.Attention was paid to the acetabulum at this time, a large amount of synovitis was removed.Again, no evidence of infection, but certainly metalosis was seen.Doi: (b)(6) 2007.Dor: (b)(6) 2023.Right 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.The product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: d4 (expiration date).
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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 (clinical codes) 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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Medical records received.Mri scan dated (b)(6) 2023 shows extensive osteolysis and large effusion within the right hip pseudojoint.
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Search Alerts/Recalls
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