It was reported that the patient continued with hip pain.Radiolucent line around cup remained and cup position changed from initial post op and follow up in office, line remained and pain continued.Concern not solid cup / acetabulum interface.It was also indicated that there was loosening of the cup at the bone to implant interface.Doi: (b)(6) 2020, dor: (b)(6) 2020, affected side: left hip.
|
Product complaint # (b)(4).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 manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|