ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION METAL IMPACTOR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
|
Back to Search Results |
|
Catalog Number 110029132 |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The customer has indicated that the product will not be returned to zimmer biomet for investigation as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that 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 an initial procedure, the impactor tip fractured.The correct surgical technique was used.No complications, injuries, surgical interventions, or foreign bodies were retained due to this malfunction.The case was completed without any adverse outcomes to the patient with an alternate impactor.Attempts have been made, and no further information has been provided.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.The reported event is unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was 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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
No further event information is available at the time of this report.
|
|
Search Alerts/Recalls
|
|
|