Catalog Number 101214060 |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 02/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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 litigation received.Litigation alleged injury, bodily impairment, lack of mobility, infection, and pain.Doi: (b)(6) 2010; dor: (b)(6) 2018; right hip.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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Product complaint # (b)(4).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 caused or contributed to the potential event described in this report.Udi: (b)(4).
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Event Description
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Ppf alleges, pseudotumor, metal wear, metallosis, and elevated metal ions.After review of medical records, patient was revised to address periprosthetic osteolysis and trunion corrosion.Added dob, revision hospital, revision surgeon, age, weight, expiration date of impacted products.Corrected dor.Doi: (b)(6) 2010.Dor: (b)(6) 2018.Right hip.
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Search Alerts/Recalls
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