Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 10/16/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10 ¿ medical devices: oxf uni tib tray sz c rm pma; item# 154723; lot# 140490, oxf anat brg rt smsize 3 pma; item# 159568; lot# 114170.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00379 , 3002806535 - 2023 - 00381.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
|
|
Event Description
|
It was reported that a patient underwent an initial partial right knee arthroplasty.Subsequently, approximately 5 years later a revision procedure due to unknown reason was performed.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Devices are used for treatment.Medical records were not provided.With the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|