Catalog Number 121722058 |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
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Patient Problems
Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 02/19/2019 |
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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Pinnacle mom litigation record received.Litigation alleges metallosis, synovitis, inflammatory process and possible loosening of acetabular and femoral component.Operative report stated a large amount of dark coagulated blood and pseudotumor.Doi: (b)(6) 2009; dor: (b)(6) 2019; right hip.
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Manufacturer Narrative
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Product complaint # (b)(4).
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Event Description
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Update ad 14 oct 2019 unf and ad 5 nov 2019 pfs:(b)(4) has been re-opened due to the receipt of unf, pfs and medical records.Pfs alleges pain.After review of the medical record, the patient was revised to address failed metal -on -metal right total hip arthroplasty with pseudotumor formation.Revision operative note reported of a large amount of dark coagulated blood and pseudotumor around the implant; acetabular shell and femoral stem are well fixed and there was no loosening of stem and cup reported.Doi: (b)(6) 2009; dor: (b)(6) 2019; 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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.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.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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