Catalog Number 00500105328 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 07/26/2023 |
Event Type
Injury
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Event Description
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It was reported a patient underwent a right hip revision approximate eight days post implantation due to a dislocation and fracture to the neck of the femur.The surgeon noted that the stem had excessive anteversion, the bipolar shell was too big.The head, liner and stem were removed and replaced.Attempts have been made and no further information is available.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-023-02177, 002648920-2023-00196.D10/d11: concomitant medical products: cat #: 802202802 / femoral head 12/14 taper 28 mm diameter +0 mm neck length / lot #: 3151441.G2: australia.The device will not be returned for analysis.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Manufacturer Narrative
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(b)(4).Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
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Event Description
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Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
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Search Alerts/Recalls
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