DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 40MM M SPEC+5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Catalog Number 136506000 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Foreign Body In Patient (2687); No Code Available (3191)
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Event Date 11/30/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.(b)(4).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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Pinnacle mom litigation records received.Litigation alleges severe pain, discomfort, injuries, emotional distress, disability, disfigurement, partial or complete loss of mobility and loss of range of motion.Doi: (b)(6) 2009 - dor: (b)(6) 2017 (left 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 device history record (dhr) review, was not possible because the required lot number 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).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 and blood heavy metal increase).
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Event Description
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Ppf alleges pseudotumor, metallosis, elevated metal ions and metal wear.After review of medical records, the patient was revised for mechanical complication joint prosthesis and failed metal on metal tha, metallosis with adverse local tissue reaction.Operative notes reported that there was a large effusion with copious light brown fluid.There was anterior osteolysis of the proximal femur which provided a nice window into the trochanteric region of osteolysis, which was repaired with a combination of cancellous chips and grafton putty.Additional bone graft was place on the trochanter.
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Search Alerts/Recalls
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