Asr medical records and implant records received.After review of medical records the patient was revised to address painful and failed right thr.Operative note reported mom hip which had elevated metal ions, clicking, discomfort, synovitis and bursitis of the joint were also noted.There is extensive fluid collection of the hip and staining of tissues suggesting recurrent hemorrhage and adverse reaction.There was lack of ingrowth in the capsule.No lab result provided for metal ion level.Doi: (b)(6) 2009; dor: (b)(6) 2019; right hip.
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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: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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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