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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
No Code Available (3191)
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Event Date 07/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 010000662 6449985 g7 pps ltd acet shell 50d, 00625006530 64339340 bone scr 6.5x30 self-tap, unknown head, unknown stem.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03770, 0001825034 - 2019 - 03772.
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Event Description
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It was reported during hip surgery, the liner would not seat into cup.A second liner was opened and used.Upon reduction, the hip was determined to be unstable.After interop x-ray was performed, it was determined that the cup had moved during impaction of the second liner.The liner and femoral stem were removed, the cup was repositioned, screws were inserted, a new liner was inserted, the stem was re-inserted and the hip was reduced.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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