Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Fracture (1260); Biocompatibility (2886); Naturally Worn (2988)
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Patient Problems
Fatigue (1849); 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); Test Result (2695); No Code Available (3191)
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Event Date 10/24/2005 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter occupation: lawyer.
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Event Description
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Litigation alleges biologic corrosion and friction wear caused cocr metal ions and particles to be released into the plaintiff's body.The right side revision surgery was due to an adverse reaction to metal debris and burnishing of the metal liner of the right hip replacement.As a result, the plaintiff suffered bodily injuries, pain, discomfort, crushing or popping noises, difficulty standing or walking, hip fractures or dislocations, fatigue, infection, necrosis, metallosis, and inflammation causing damage or death to surrounding bone and tissues.
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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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Manufacturer Narrative
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Patient code: no code available (3191) used to capture the surgical intervention.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.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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