Model Number 02.12.0610FR |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Joint Laxity (4526)
|
Event Date 10/14/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
Batch review performed on 18-oct-2022: lot 2002808: (b)(4) items manufactured and released on 10-jun-2020.Expiration date: 2025-06-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
|
|
Event Description
|
At about 1 year and 9 months after the primary surgery, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the insert (10 mm) with a thicker one (12mm) and the surgery was completed successfully.
|
|
Search Alerts/Recalls
|