Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product location 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: 0001825034-2020-00693.
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Event Description
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It was reported that during a hip procedure, the liner was unable to be sat or locked into the cup.A new liner was used to complete the surgery.There was no reported harm or injury to the patient.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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Complaint sample was returned and evaluated.Visual inspection identified the locking feature has been shaved but is still connected to the device.The some of the scallops on the device have been damaged or shaved off.Dhr was reviewed and no discrepancies were found.The root cause is 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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