It was reported that the sales consultant was called this am by the or that there was an i&d with the surgeon.He arrived just after the incision was made and was able to obtain some information regarding the case.This patient was told to come into the er to be admitted and would undergo a hip i&d.This patient had his hip replaced on (b)(6) 2021 at (b)(6) hospital and recently began experiencing redness and drainage from his wound.During the i&d the hip ball and pinnacle liner were explanted and exchanged for new products.The 7hi summit stem and 60mm pinnacle sector cup were left in situ.Doi: (b)(6) 2021, dor: (b)(6) 2021, 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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