Catalog Number 010000858 |
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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Event Description
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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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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00742 and 0001825034-2023-00743.Concomitant medical products: cat #: 010000665 / g7 pps ltd acet shell 56f / lot #: 7006364 cat #: 010000936 / g7 hi-wall e1 liner 36mm f / lot #: 6999247.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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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The liner was returned and evaluated against the complaint.Visual inspection found a gouge near the apex of the outer radius.Dings and light damage are also present on the outer radius.The inner rim of the liner has been damaged.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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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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