MPACT ACETABULAR SYSTEM
Received Jul 9, 2026 · Event occurred Jun 25, 2026
Report 3005180920-2026-00706 · MDR key 25763493
Device
Generic name
Acetabular Shell Ø48 No-hole
Manufacturer
Medacta International SaModel number
01.32.148SHLot number
2109431
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Joint Impingement
Narrative
Additional Manufacturer Narrative
BATCH REVIEW PERFORMED ON 26 JUNE 2026 LOT 2109431: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-DEC-2021. EXPIRATION DATE: 14-OCT-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.
Description of Event or Problem
THE PATIENT CAME IN PRESENTING PAIN DUE TO CUP - ILIOPSOAS IMPINGEMENT AND THE CAUSE IS UNKNOWN. IT HAS BEEN REPORTED THAT PROBABLY THE CUP WAS NOT MEDIALIZED ENOUGH AND HAS BEEN MALPOSITIONED, BUT THERE IS NO CONFIRMATION OF THIS INFORMATION. ABOUT 4 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR IMPLANTS AND REVISED THE HEAD WITH AN L SIZE AND SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.