Catalog Number 010000665 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00743, 0001825034-2023-00744.Concomitant medical products: cat #: 010000936 / g7 hi-wall e1 liner 36mm f / lot #: 6999247, cat #: 010000858 / g7 neutral e1 liner 36mm f / lot #: 7151613.Report source: china.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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Event Description
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Hold sac 4/4/23 it was reported, that during an initial procedure, the liner did not match the cup properly.A new liner was opened and the second liner also did not match correctly with the cup.There were no health consequences or impact to the patient.Attempts have been made and no further information is available.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3; h6 the shell was returned and evaluated against the complaint.Visual inspection found the shell to be in overall good condition.No damage or scratching was observed on the inner radius or to the locking groove of the shell.The complaint is confirmed based on the returned device.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to 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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Search Alerts/Recalls
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