Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: catalog number:00620005022 lot number: 61801109 brand name: trilogy cup.Catalog number: 00631005032 lot number: 61771176 brand name: xlpe liner.Catalog number:00801803203 lot number: 61803912 brand name: cocr head.Catalog number: 00625006530 lot number: 61832519 brand name: bone screw.Catalog number:00786401100 lot number: 00115660 brand name: tm stem.Multiple reports were submitted along with this report 0002648920-2022-00148.0001822565-2022-01939.0002648920-2022-00149.0001822565-2022-01940.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device 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 that the patient experienced pain in the upper side of the hip and alleged sensation of the tendon moving within the joint approximately 11 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g3; h2; h3; h6.Corrected: d4 (udi).D4 (udi) : n/a.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.
|
|
Event Description
|
No additional event information to report at this time.
|
|
Search Alerts/Recalls
|