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Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)
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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 02/02/2012 |
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 biologic corrosion and friction wear caused cocr metal ions and particles to be released into the plaintiff's body resulting to 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.The pinnacle implants were removed which included an unstable left total hip arthroplasty due to an adverse reaction to metal and burnishing of the metal liner.Doi: (b)(6) 2010; dor: (b)(6) 2012; (left hip).Head doi: (b)(6) 2011.
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Manufacturer Narrative
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(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.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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Search Alerts/Recalls
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