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Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 11/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: revitanâ®, proximal part, cylindrical, uncemented, 65, taper 12/14 item # 0100402065 lot # 2799951 g2: foreign: germany.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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Event Description
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It was reported that there was a surgery revision due to pain caused by a cone fracture at the p part of curved stem connection.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was identified as a duplicate case, the reportability will be completed in mdr349489 (mrf report number: 0009613350 - 2023-00636).The initial report was forwarded in error and should be voided.
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Event Description
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Upon reassessment of the reported event, it was identified as a duplicate case, the reportability will be completed in mdr349489 (mrf report number: 0009613350 - 2023-00636).The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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