Model Number 42-5320-067-01 |
Device Problems
Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
|
Patient Problems
Failure of Implant (1924); Pain (1994)
|
Event Date 07/14/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Medical product: articular surface fixed bearing posterior stabilized (ps) left 11 mm height: catalog#42512400511, lot#63857585; femur cemented posterior stabilized (ps) standard left size 8: catalog#42500606401, lot#63636841; all-poly patella cemented 29 mm diameter: catalog#42540200029, lot#63842186; cobalt hv bone cement 40g: catalog#402282, lot#288550; cobalt hv bone cement 40g: catalog#402282; lot#440420.Foreign: japan.Multiple mdr reports have been filed for this event.Please see associated reports: 3007963827-2022-00199; 3007963827-2022-00200; 0001825034-2022-01811; 0001825034-2022-01812.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that a patient underwent an initial total knee arthroplasty.Approximately two years post-implantation, the patient started to experience pain in the knee.The products were ultimately revised four years and four months post initial implantation.During the surgery, the articular surface was found to be worn, the tibial component was found to have loosened and migrated, and the femoral component was loosened.The surgeon theorized that the loosening was caused by an inflammatory reaction to abrasion particles and cement technique error.It was reported that no further information is available.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related to the reported event were found.It is alleged that the loosening is due to cementing technique error however without medical records a definitive root cause was unable to 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 at time of this report.
|
|
Search Alerts/Recalls
|