Catalog Number 121720500 |
Device Problems
Fracture (1260); Loss of Osseointegration (2408)
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Patient Problems
Cyst(s) (1800); Pain (1994); Tissue Damage (2104); Weakness (2145); Hypoesthesia (2352); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)
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Event Date 09/18/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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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Claim and medical records received.After review of claim and medical records, it was stated that the patient was revised to address pain and aseptic loosening of cup component.Stiffness, limping, clicking, popping, weakness and numbness were also noted.Operative notes reported slightly brown tented and translucent fluid, the tissue is stained dark gray consistent of metallosis, two superior cysts were curetted and there was no acetabular bony ingrowth noted.When removing the acetabular shell, three screws broke but only one was fully extracted and the two screws were recessed since they were embedded into the sclerotic bone.Mri reported trochanteric bursitis.X-ray reported aseptic loosening of acetabular component and has metal wear debris reaction.Doi: (b)(6) 2010; dor: (b)(6) 2018; left hip.
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Manufacturer Narrative
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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.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot: null.Device history batch: null.Device history review: null.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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