DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE SECTOR II CUP 52MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
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Catalog Number 121722052 |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Muscle Spasm(s) (1966); Pain (1994); Distress (2329); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Not Applicable (3189)
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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.Attorney.
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Event Description
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Pinnacle litigation received.Litigation alleged pain, decreased mobility, metallic debris, loosening from acetabulum, injury, and emotional distress.Doi: (b)(6) 2006; dor: unknown; left hip.
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Manufacturer Narrative
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Investigation summary: 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 code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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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Manufacturer Narrative
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Product complaint # (b)(4).Udi: (b)(4).
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Event Description
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Ppf alleges metallosis and elevated metal ions but laboratory result was below normal level.Pfs also alleges limp, trouble walking, muscle spasm in thigh & hip area.After review of medical records, patient was revised to addressed mechanical complications left metal on metal tha.Revision notes indicated pocket of fluid that was mild in terms of metallosis.It was non purulent.It had less of the appearance of a pseudotumor but nonetheless there was some metallic wear debris that stained the soft tissues.The cup remained well aligned and well-fixed with no evidence of loosening.Also stem appeared well fixed.The sciatic nerve was palpated and noted to be intact with no undue tension.Added demographic data of patient, account name, surgeon date of revision, medical history, laboratory result and product details of liner, head and cup in impacted product.Doi: (b)(6) 2006; dor: (b)(6) 2016; 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.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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