Catalog Number 00598801116 |
Device Problems
Material Erosion (1214); Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
|
Patient Problems
Failure of Implant (1924); Metal Related Pathology (4530)
|
Event Date 09/28/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10: medical product: unknown rotating hinge knee femoral component: catalog#: ni, lot#: ni; unknown femoral augment 10mm: catalog#: ni, lot#: ni, qty#2; unknown rotating hinge knee tibial tray: catalog#: ni, lot#: ni; 17mm height size d articular surface with hinge post extension: catalog#: 00588004017, lot#: 65566971.G2: foreign: germany.Additional mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-02922; 0001822565-2023-02924; 0001822565-2023-02925; 0001822565-2023-03757.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient developed metallosis and loosening of the femoral component.It was also suspected that the connection between the femoral stem and femoral cone implants is fractured.Subsequently, the patient underwent revision surgery of the femoral components.Due diligence is in progress for this event, to date no further information has been reported.
|
|
Event Description
|
It was reported that a patient underwent an initial right total knee arthroplasty on an unknown date.On an unknown timeframe post-implantation, the patient developed metallosis and loosening of the femoral component.It was suspected that the connection between the femoral stem and femoral cone implants fractured.Subsequently, the patient underwent additional surgery to re-cement the femoral components and they were left in place.A full revision surgery was planned for a later date.Due diligence is complete as multiple attempts have been made however no further information has been made available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - stem.An additional mdr report was filed for the subsequent revision surgery involving this device.Please see associated report: 0002648920-2024-00091.The reported device was returned to the manufacturer following explantation at a later date.The device was also evaluated pertaining to this event.Visual examination of the product identified signs of implantation.For the femoral stem, it is found to have damage to the taper connection.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was unable to be confirmed.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.
|
|
Search Alerts/Recalls
|