FDA Adverse Event Injury Summary report: N

AMISTEM C FEMORAL STEMS

MDR report key: 25297685 · Received May 27, 2026

Report

Report Number: 3005180920-2026-00530
Event Type: Injury
Date Received: May 27, 2026
Date of Event: May 14, 2026
Report Date: May 27, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: LZO
UDI-DI: 07630030803802
PMA / PMN Number: K103189
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 18 MAY 2026 STEM: AMISTEM C 01.18.102 AMISTEM-C LAT. SIZE 2 (K103189) LOT 2000006: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2020. EXPIRATION DATE: 07-MAY-2025. 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 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 AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem · 0

AT ABOUT 3 YEARS AND 11 MONTHS FROM THE PRIMAR, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED ALL MEDACTA IMPLANTS TO COMPETITOR IMPLANTS. THE SURGERY WAS SUCCESSFULLY COMPLETED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
324710	AMISTEM C FEMORAL STEMS	AMISTEM-C LAT. SIZE 2	LZO	MEDACTA INTERNATIONAL SA	01.18.102	2000006	07630030803802

Patients

Seq	Age	Sex	Outcome	Treatment
1