Model Number N/A |
Device Problem
Unstable (1667)
|
Patient Problems
Failure of Implant (1924); Ambulation Difficulties (2544)
|
Event Date 06/29/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).D10 - medical product: series a pat std 34 3 peg catalog # 184766 lot # 027070.Bmt splined knee stm 18x80 catalog # 141618 lot # 772440.Offset tib tray 5.0mm adaptor catalog # 141491 lot # 591140.Vngd ssk intlk fmrl 70 lt catalog # 183326 lot # 050040.Biomet offset tibial tray 75mm catalog # 141484 lot # 077120.Vngd ssk ps tib brg 12x71/75 catalog # 185082 lot # 071370.H3: customer has indicated that the product will not be returned because it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported patient is experiencing instability and noise in knee six months post implantation.Radiograph noted the screw was found to have backed out.Attempts to obtain additional information have been made; however, no more is available.
|
|
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 following sections were updated: h6: mechanical (g04) - stem.Reported event was confirmed by review of medical records provided.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.Medical records review indicates that patient noted grinding and the knee was buckling.Screw was found to be backed out in x-rays.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.
|
|
Search Alerts/Recalls
|