Model Number 1218-87-352 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
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Patient Problems
Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Limb Fracture (4518); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 04/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #:(b)(4).Initial reporter occupation: lawyer.Follow-up is being conducted to determine initial reporter contact information.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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Event Description
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Litigation record received.Patient alleges pain and suffering, serious bodily injuries, and economic loss.Doi: (b)(6) 2007 - dor: (b)(6) 2019 (right 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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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Pinnacle pfs alleges displaced fracture of the lesser trochanter of the right femur, osteolysis, wear, trunnionnosis, bone fragments, fibrous tissue, scattered foreign materials, cyst, necrosis, hemorrhagic debris, prosthesis loosening and elevated metal ions.Medical records received.After review of the medical records the patient was revised due to osteolysis and wear right tha.Operative note reported moderate trunnionosis and wear on the femoral head and liner.There was a osteolytic cyst and large amount of blackened osteolytic tissue and lesion.Some comminuted fragments of the lesser trochanter.Clinical visit reported pain, weakness, walking difficulty, cyst, click in the hip, mri reported osteolytic lesion at the lesser trochanter of the femur, femoral calcar, pathologic avulsion fracture of the lesser trochanter with medical displacement of the trochanter, osteolysis, joint effusion, pseudotumor, metastatic disease.Lab result shows above 7 ppb.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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Search Alerts/Recalls
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