Product complaint # (b)(4).(b)(4) - dec 14 2022.(b)(4) operative notes ad 07 dec 2022 were reviewed by clinician.On (b)(4) 2022 the patient had a right press-fit total hip arthroplasty to address primary osteoarthritis, end-stage.Depuy components were used during this procedure.The surgeon observed that there was slight crack in the calcar, so cerclage wires were placed.There was noted to be excellent stability of the stem.There is no new information provided that requires additional patient or product codes for the ips, nor does it change the existing us-fda mdr reportability determinations.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.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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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.All available x-rays were reviewed, and no evidence of implant fracture or anything indicative of a device nonconformance was found.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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