Patient was revised to address disassociation.Patient presented with disassociated bipolar construct.Upon incision and inspection of hip joint, it was discovered that the polyethylene portion of the construct was fractured in half.The 28mm head, 45mm bipolar shell, and the 2 pieces of polyethylene were all recovered from the patient w/o any adverse events.A new bipolar construct was chosen and implanted w/o issue.It was also reported that the 28mm head from the bipolar construct was loose.Doi: unknown; dor: (b)(6) 2018; unknown hip.
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(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.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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