FDA Adverse Event Injury Summary report: N

QUADRA H FEMORAL STEMS

MDR report key: 25185337 · Received May 15, 2026

Report

Report Number: 3005180920-2026-00458
Event Type: Injury
Date Received: May 15, 2026
Date of Event: April 28, 2026
Report Date: May 15, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JDI
UDI-DI: 07630030802140
PMA / PMN Number: K082792
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 04 MAY 2026 STEM: QUADRA-H 01.12.032 QUADRA STEM QUADRA LATERIZED HAP 12/14 S2 (K082792) LOT 174405: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2017 EXPIRATION DATE: 28-NOV-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A CONFIRMED LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA FLAT PE HC LINER D 36/E TO A MEDACTA DOUBLE MOBILITY HC LINER D 28/DMC AND CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
152117	QUADRA H FEMORAL STEMS	QUADRA STEM QUADRA LATERIZED HAP 12/14 S2	JDI	MEDACTA INTERNATIONAL SA	01.12.032	174405	07630030802140

Patients

Seq	Age	Sex	Outcome	Treatment
1