Model Number N/A |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/06/2022 |
Event Type
malfunction
|
Event Description
|
It was reported the liner would not fully seat with the cup.The patient's bone quality was too poor; therefore, the surgery was completed with bipolar devices.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.
|
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: cat# 11-165236 lot 497960 ringloc bi-polar zimmer cat# 192412 lot 000260 echo por fmrl.Cat # 00625006520 lot j7360863 bone scr.Cat # 00625006520 lot j7373554 bone scr.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-03566.The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
No further information at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified liner was returned partially seated in the shell.Liner shows damage to the locking feature and anti-rotation scallops.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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.
|
|
Search Alerts/Recalls
|