Model Number N/A |
Device Problem
Insufficient Information (3190)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/02/2023 |
Event Type
Injury
|
Event Description
|
It was reported that the patient was revised due to unknown reasons.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01128, 0001822565-2023-01127.D10: tm reverse dual taperspacer impactor tm reverse dual taper/spacer impactor cat: 00430903900 lot: 62379035.Unknown tm reverse 6mm humeral spacer.Unknown tm reverse humeral baseplate size 36 +0.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.
|
|
Event Description
|
No further event information available at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: mechanical (g04) - head.
|
|
Search Alerts/Recalls
|