FDA Adverse Event Injury Summary report: N

MPACT ACETABULAR SYSTEM

MDR report key: 24162759 · Received January 23, 2026

Report

Report Number: 3005180920-2026-00042
Event Type: Injury
Date Received: January 23, 2026
Date of Event: January 5, 2026
Report Date: January 23, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LPH
UDI-DI: 07630345798763
PMA / PMN Number: K230011
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 9 JANUARY 2026. CUP: MPACT 01.32.154DHT ACETABULAR SHELL D 54 TWO-HOLES T (K230011) LOT 2511723: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUL-2025. EXPIRATION DATE: 06-JUL-2030. 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:ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

Description of Event or Problem · 0

AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE CUP AND IT WAS DETERMINED THAT THERE WAS NO BONE GROWTH ON THE IMPLANT WHICH WAS THE CAUSE. THE SURGEON REVISED THE D 54 SHELL TO A D 62 MULTI-HOLE SHELL, THE 36MM BIOLOX HEAD S TO A 36MM BIOLOX XL. AND THE D 36/F LINER TO A D 36/G LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
228592	MPACT ACETABULAR SYSTEM	ACETABULAR SHELL Ø54 TWO-HOLES T	LPH	MEDACTA INTERNATIONAL SA	01.32.154DHT	2511723	07630345798763

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male	Required Intervention