Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problems
Tissue Damage (2104); No Code Available (3191)
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Event Date 03/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: item# 010000937 g7 hi-wall e1 liner 36mm g lot# 6126165; item# 010000936 g7 hi-wall e1 liner 36mm f lot# 6256797.Foreign source: (b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01241; 0001825034-2019-01240.
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Event Description
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It was reported that during a total hip arthroplasty, the liner would not lock into the shell after multiple attempts.The cup was removed and a new cup was implanted.A new liner was attempted to be seated and this liner still would not seat after multiple attempts.A ceramic liner was then used in the new shell to complete the procedure.There was a delay in surgery of 90 minutes and there was a reported increase in surgical wound trauma due to the malfunction.No additional patient consequences were reported.Attempts to obtain additional information was made; however, none was available.
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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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Manufacturer Narrative
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(b)(4).Udi# - (b)(4).Complaint sample was evaluated and the reported event was confirmed.Reported event was confirmed as the device was returned and evaluated.Upon visual inspection, visible damage of the liners were noted.The shell showed no visible damage.Device history record (dhr) was reviewed and no discrepancies 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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