(b)(4) concomitant medical products: 00801803202 ¿ cocr head ¿ 60586027, 00630505032 ¿ xlpe liner ¿ 60560325, 00620005222 ¿ trilogy shell - 60541016, 00625006530 ¿ bone screw ¿ 60601931, 00625006535 ¿ bone screw ¿ 60586310.Customer has indicated that the product will not be returned to zimmer biomet for the investigation, as the product location is unknown.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: 0002648920-2020-00259 and 0002648920-2020-00260.
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g4; h2; h3; h6.Reported event was confirmed by review of medical records noting patient underwent a revision surgery due to open wound over the incision site.Altr was noted during the procedure along with corrosion with black staining layer around the trunnion.Cocr levels noted to have decreased, but still elevated after the procedure.Dhr was reviewed and no discrepancies were found.The root cause is unable to be determined.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.
|