Catalog Number 154727 |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 03/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products- medical products - oxf twin-peg cmntd fem lg pma, catalog# 161470, lot # 124620 and oxf anat brg rt lg size 6 pma, catalog# 159585 lot# 280110.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported the patient underwent a right partial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to failed tibial component.All components were removed and replaced with total knee implants.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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This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported the patient underwent a right partial knee arthroplasty.Subsequently, the patient underwent a revision procedure approximately two years post-implantation due to tibial component loosening.All components were removed and replaced with total knee implants.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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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from customer.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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