Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pain (1994)
|
Event Date 02/19/2024 |
Event Type
Injury
|
Manufacturer Narrative
|
Zimmer biomet complaint (b)(4).G2: foreign - united kingdom.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that the patient underwent tmj replacement surgery on an unknown date.Approximately one year ago the implants were removed due to chronic persistent pain.A new custom implant was ordered and will be implanted at a later date.Attempts have been made and no further information has been provided.
|
|
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.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Event Description
|
It was further reported that the product was removed over a year ago due to chronic and persistent post-operative pain which began immediately after the product was implanted and was relieved when the product was explanted.
|
|
Search Alerts/Recalls
|