Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Fall (1848); Failure of Implant (1924); Pain (1994)
|
Event Date 11/16/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient underwent a knee arthroplasty revision to address instability and aseptic loosening of the tibial and femoral components nearly three (3) years post-operatively.Attempts have been made, however, no additional information is available.
|
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: concomitant devices: persona partial knee cemented tibial component size f right medial catalog #: 42538000602 lot #: ni, persona partial knee cemented femoral component size 6 right medial catalog #: 42558000602 lot #: ni.Report source: foreign: (b)(6).The complainant has not yet indicated whether the product will 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 patient; please see all reports associated with this event: 0001825034-2022-00650, 0001825034-2022-00651.
|
|
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 device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information provided.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.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional and corrected information.D10 - concomitant devices - persona partial knee cemented femoral component size 6 right medial catalog #: 42558000602 lot #: 63947491, persona partial knee cemented tibial component size f right medial catalog #: 42538000602 lot #: 64119546.
|
|
Event Description
|
It was reported that the patient underwent a knee arthroplasty revision to address pain, instability and suspected loosening of the tibial and femoral components nearly three (3) years post-operatively.During the revision, hemarthrosis and evidence of trauma were identified, however, the components were well-fixed.None of the implants were visibly damaged and there was no evidence of infection and only early evidence of degenerative change elsewhere in the knee.Attempts have been made, however, no additional information 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.H6: type of investigation - insufficient information available is n/a which was reported on initial report.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.Additional information does not affect previous the root cause.Medical records review indicates (b)(6) 2020 patient fell onto flexed knee, reports pain; 16-nov-2021 revision: conversion to nexgen components, components were not obviously loose and need to be removed with osteotomes; (b)(6) 2022 from per instability.Radiographs review indicates there is mild osteopenia.Overall fit of the hardware is appropriate.No bony fracture.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
|