It was reported that the original surgery was on (b)(6) 2021.Went in for wash out on (b)(6) 2021 and changed poly, metal liner, head, and screws.Explanted due to recurrent infection, convert to abx spacer.Doi: (b)(6) 2021 (stem, cup); dor: (b)(6) 2021 1st revision (head, bi mentum liner, dual mobility liner, 2 screws); (b)(6) 2021 2nd revision (head, bi mentum liner, dual mobility liner, 2 screws, stem, cup) affected side: right hip.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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: the product investigation found no evidence suspecting an error in the material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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