Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)
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Patient Problems
Fatigue (1849); Bone Fracture(s) (1870); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Tissue Damage (2104); Discomfort (2330); Injury (2348); Joint Dislocation (2374); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 01/22/2008 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Pinnacle mom litigation record received.Litigation alleges corrosion and friction and wear caused cobalt-chromium metal ions and particles released into the blood, tissue and bone resulting to infections, pain, discomfort, crunching or popping noises, walking difficulty, hip fractures or dislocations, fatigue, tissue inflammation, necrosis or metallosis and lack of mobility, doi: (b)(6) 2006; dor: (b)(6) 2008; right 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).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.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.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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Search Alerts/Recalls
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