(b)(4).D10 - concomitant devices - persona partial cemented femoral component size 7 left medial catalog #: 42558000701 lot #: 64986990, persona partial cemented tibial component size g left medial catalog #: 42538000701 lot #: 65503040.The complainant has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.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: 0001825034-2023-02157.0001825034-2023-02158.0001825034-2023-02159.H3 other text : investigation incomplete.
|
This follow-up report is being submitted to relay additional information.Visual evaluation of pictures provided confirmed foreign material and bone cement on the tibial and femoral implants, however, no images of the articular surface were provided.Radiographic review identified radiolucency along the tibial implant which appeared loose, but not displaced.The patient's bone quality appeared osteopenic, however, no other abnormalities were identified.The device history records were reviewed and no discrepancies were identified.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.
|