It was reported that this patient fell in rehab and dislocated her hip.Dr.(b)(6) was unable to reduce it without doing an open reduction.He wanted to increase her bipolar head size to a 43mm to increase stability.After trialing and put her through a range of motion it was noted to be stable.Doi: (b)(6) 2021, dor: (b)(6) 2021, 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.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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