Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 04/19/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device 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 patient underwent initial hip arthroplasty involving an avenir system.Subsequently, the patient was revised approximately 2 months post implantation due to infection.Additional information on the reported event is unavailable at this time.
|
|
Manufacturer Narrative
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
|
|
Event Description
|
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
|
|
Search Alerts/Recalls
|