Model Number N/A |
Device Problem
Difficult or Delayed Positioning (1157)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/25/2022 |
Event Type
malfunction
|
Event Description
|
It was reported the screw connecting the proximal body and distal stem had a hard time tightening and loosening.Attempts have been made and additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
(b)(4).Concomitant medical products: 11-300816- arcos 16x150mm spl tpr dist- 943650.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00649.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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 information on the reported event.
|
|
Search Alerts/Recalls
|