Model Number 1217-03-052 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 11/12/2012 |
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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Unf and medical records received.After review of medical records, the patient complains of worsening right hip and groin pain and had increased metal ions, as well as cross-table lateral of the pelvis showing increased anteversion potentially leading to edge loading.The patient was then revised for right metal on metal total hip.Total hip arthroplasty with elevated metal ions.Operative notes reported that there was noted to be metallosis around the surrounding soft tissues even prior to entering in the capsule.There was noted to be a significant amount of greenish black soft tissue debris.The taper was examined and there was a slight amount of grayish material consistent with a small amount of taper corrosion, but overall the taper looked fine.There was some scuff marks on the posterior lateral aspect of the of neck of the prosthesis possibly due to impingement on the posterior aspect of the acetabular component.The acetabulum appeared to be significantly anteverted.There was no significant bony ingrowth on the cup.Doi: (b)(6) 2007; dor: (b)(6) 2012; right hip.
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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. this is a duplicate report of mfr# 1818910-2018-77583.Mfr# 1818910-2020-05632 is being retracted as it a report duplication.Mfr# 1818910-2018-77583 will be kept for investigation purposes.
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Search Alerts/Recalls
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