Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The product has been returned to zimmer biomet for investigation.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: 0001825034 - 2021 - 02948.
|
|
Event Description
|
It was reported that there was a problem with the packaging of the taperloc stems.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.Visual evaluation of the returned product/photographs provided found abrasions and holes in the sterile pouches.The reported event is confirmed.Sterility, or breach thereof, cannot be determined as the sterile blister was not returned for evaluation.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event can be attributed to transit damage and a packaging design issue.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 further event information available at the time of this report.
|
|
Search Alerts/Recalls
|