It was reported that patient came to er dislocated.Surgeon explanted current 53 unipolar head ball and +5 tapered sleeve and began trialing with + 5 28 mm and 53 bipolar head ball without luck of stability.He then trialed with +8.5 28mm head ball and still was dissatisfied with stability.He decided to explant summit stem (8std) and implant 8 hi summit stem with + 5 28mm head ball with a dual mobility competitor mdm cup.Surgeon stated he was displeased with depuy¿s ability to provide a dual mobility pinnacle implant.Original implant date unknown.Doi: unknown, dor: (b)(6) 2020, affected side: left 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.
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