Model Number N/A |
Device Problem
Unstable (1667)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/16/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Oxf uni tib tray sz b lm pma, item# 154720, lot# 6499378; oxford uni twin-peg femoral md, item# 166942, lot# j6561560.Foreign ¿ australia.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2023-00186.3002806535-2023-00188.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 patient underwent knee revision surgery due to instability about three (3) years after initial surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
|
|
Manufacturer Narrative
|
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.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
|
Upon further assessment of the reported event, it was determined that medwatch report should not have been filed as there was no indication that the device caused or contributed to a serious injury.Given this information, this medwatch report will be voided.
|
|
Search Alerts/Recalls
|