Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Naturally Worn (2988)
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Patient Problems
Edema (1820); Inflammation (1932); Pain (1994); Discomfort (2330); Toxicity (2333); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 06/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(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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Pinnacle mom litigation record received.Litigation alleges friction and wear between cobalt-chromium metal head and liner caused large amount of metal ions and particles into blood, tissue and bone resulting to pain, discomfort and inflammation.Doi: (b)(6) 2009; dor: (b)(6) 2019; left 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.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 : null.Device history batch : null.Device history review : null.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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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 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.H10 additional narrative: 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, 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 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. h10 additional narrative: udi: (b)(4).Added: a2 (dob, and age), a4, and h6 (patient and device).H6 patient code: no code available (3191) used to capture the device revision or replacement and blood heavy metal increased.
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Event Description
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Pfs, ppf and medical records received.In addition to what were previously alleged, ppf alleges metal wear, metallosis, and elevated metal ions.Pfs alleges metal toxicity, and pain in hip joint with limited mobility.Patient reported persistent pain.Radiographs revealed questionable loosening of the acetabular component.Further workup revealed elevated serum metal ion levels.After review of medical records, patient was revised to address status post left total hip arthroplasty with persistent pain, and metal on metal bearing left hip with elevated metal serum metal ion levels.Operative notes stated clear synovial fluid upon arthotomy.No gross evidence of infection.Inadequate osseointegration of the acetabular component with malposition.One bone screw was removed because the head of it was stripped.
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Search Alerts/Recalls
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