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Catalog Number UNK HIP FEMORAL HEAD |
Device Problems
Corroded (1131); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Weakness (2145); Distress (2329); Injury (2348); Osteolysis (2377); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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.Brand name, common device name, procode, lot #, part #, udi #, 510k: 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 litigation records received alleging scar tissue, elevated blood cobalt levels, injury, pain, suffering and emotional distress.Update: it was stated that the primary surgery date was on (b)(6) 2008.The revision date was on (b)(6) 2019.It was also alleged that the patient suffered from joint effusion, muscle damage and muscle weakness.Doi: unknown; dor: unknown; (unknown hip).
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Manufacturer Narrative
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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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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 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. no code available (3191) is used to capture (medical device removal).
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Event Description
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Ppf alleges pseudotumor, metallosis and metal wear.Updated code for scar and effusion.After review of medical records patient was revised to addressed aseptic failure, left hip, status post total hip arthroplasty with metal on metal implant with subsequent metallosis.Operative findings of extensive metallosis within the synovial space with a pseudotumor forming in the area of the greater trochanter.Operative notes indicated swollen trochanteric bursa that was filled with fluid, was aspirated and sent for culture and sensitivity, removed the remaining inflammatory tissue, extensive metal staining and metallosis appearing tissue within synovial space.Femoral head was removed with extensive corrosion along the trunnion as well.Added medical history, height and weight of patient.Doi: (b)(6) 2008, dor: (b)(6) 2019 left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this complaint was not returned.X-rays provided were reviewed and found insufficient information to confirm any implant related issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing records evaluation (mre) was not performed as investigation could not retrieve a lot number.
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Search Alerts/Recalls
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