|
Model Number N/A |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
Tissue Damage (2104)
|
Event Date 07/18/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 114813, disc ulna 3x75mm rt w/brng c, 580370.114700, disc condyle kit w/ hexalobula, 307490.(b)(6).Udi - (b)(4).The complaint is confirmed based on the pictures that were provided.Review of device history records found these units were released to distribution with no related deviations or anomalies.A definite root cause has not been determined at this time.Corrective action was initiated to further investigate root cause.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
|
It was reported that during a total elbow arthroplasty procedure, it was discovered that screws that were not intended to be in the device following manufacturing, were found screwed into the device.The surgery was delayed, as the implant was already cemented in the patient and additional bone was required to be removed to implant a new component.No additional information is provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Only thread plugs were received.Implant was not returned.Examination of the returned thread plugs confirms the report.The thread plugs were meant to be removed during the manufacturing process.Investigation remains unchanged as previously reported.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 information available.
|
|
Search Alerts/Recalls
|
|
|