Catalog Number 010000926 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 02/21/2024 |
Event Type
Injury
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Event Description
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It was reported that during the procedure, the liner was not able to be assembled with the shell.While the surgeon was attempting to assemble the items, the bone gave away and the shell was protruding from the acetabulum.Another cup and liner were used to complete the procedure.It was reported that 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: 0001825034-2024-00703.D10: cat #: 110017102 / g7 finned 3 hole shell 50d / lot #: 7510004.G2: mexico.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified both show signs of use with bio-debris in the coating of the shell and damage to the scallops and od of the liner.Measured features f28 and f10 on the print for the liner and both were conforming.Also measured features f66 and f71 on the shell and they were both conforming as well.The complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.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 additional event information to report at this time.
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Search Alerts/Recalls
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