Model Number N/A |
Device Problem
Unstable (1667)
|
Patient Problem
Nerve Damage (1979)
|
Event Date 01/29/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10 - medical product: articular surface fixed bearing cruciate retaining (cr) catalog # 42522000610 lot # 65384864 tibia cemented catalog # 42532007902 lot # 65502804 g2: australia multiple mdr reports were filled for this event: 3007963827-2024-00043 h3: customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : product location unknown.
|
|
Event Description
|
It was reported patient underwent a revision procedure eleven months post implantation due to instability and femoral nerve damage.Attempts to obtain additional information have been made; however, no more is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Suggested component code: mechanical (04)- femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot 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.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Search Alerts/Recalls
|