Catalog Number 01.32.148MB |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Implant Pain (4561)
|
Event Date 11/30/2023 |
Event Type
Injury
|
Event Description
|
At 5 months and a half from the primary, the patient came in reporting pain due to impingement by the cup.The surgeon revised the 48mm cup with a 52mm cup and added more inclination.The surgeon also revised the head and liner and added a biolox option sleeve.The surgery was completed successfully.
|
|
Manufacturer Narrative
|
Batch review performed on 04 december 2023 lot 2219702: 32 items manufactured and released on 14-feb-2023.Expiration date: 2028-jan-29.No anomalies found related to the problem.To date, 24 items of the same lot have been sold with no similar reported event during the period of review.
|
|
Search Alerts/Recalls
|