Model Number N/A |
Device Problems
Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bone Fracture(s) (1870); Failure of Implant (1924)
|
Event Date 06/18/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical devices: 178512 - cps nut co-cr-mo alloy - 250400; 178711 - cps/oss 5cm tpr adapt w/oss sc 5cm - 490530; 178525 - cps transverse pin 6pk 24mm m - 524250; 178364 - cps xs sht spdl w pins 800lbf - 814940; 178367 - cps sm sht spdl w pins 800lbf - 235970; 150483 - oss segmental stacking adapter - 933720; 161011 - oss rs 7 cm mod seg fmrl-rt - 678610; 150476 - oss poly tibial bushing - 221860; 150478 - oss poly lock pin - 490730; 150493 - oss reinforced yoke - 570110; 161034 - oss rs poly fem bushings set/2 - 494980; 161035 - oss rs axle - 619830; 161018 - oss rs non-mod plate short 59 - 728720; 150466 - oss 7cm diahpyseal segment - 119960; 161094 - oss rs 12mm ls tibial bearing - 887140.The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted. multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01937, 0001825034-2021-01938, 0001825034-2021-01939, 0001825034-2021-01940, 0001825034-2021-01941.
|
|
Event Description
|
It was reported the patient underwent a right knee procedure.Subsequently, the patient was scheduled to be revised due to a failed compress.The patient then underwent a revision surgery one week after initial implantation.Attempts have been made and no further information has been provided.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported the patient underwent a right knee procedure.Subsequently, the patient was scheduled to be revised due to a failed compress.The patient then underwent a revision surgery one week after initial implantation.The traction bar appears to have bent.The surgeon stated he is unsure if the fractured bone was an effect or a cause of the failed compress.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
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.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.X-rays were provided and reviewed by a health care professional.Review of the available records identified the following: periprosthetic fracture at the mid to distal femoral diaphysis with mild apex lateral angulation.Alignment is abnormal with apex lateral angulation between the bone and hardware interface.Bone quality appears normal.A definitive root cause cannot 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
|