FDA Adverse Event Injury Summary report: N

GMK TOTAL KNEE SYSTEM

MDR report key: 25253483 · Received May 22, 2026

Report

Report Number: 3005180920-2026-00477
Event Type: Injury
Date Received: May 22, 2026
Date of Event: May 4, 2026
Report Date: May 22, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630345716200
PMA / PMN Number: K211004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 06 MAY 2026 GMK-SPHERIKA 02.12.KA12R GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED (K211004) LOT 2427690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2024. EXPIRATION DATE: 28-NOV-2029. 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 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 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO FEMORAL LOOSENING AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE CEMENTED FEMORAL COMPONANT AND THE INSERT (FROM 11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
190374	GMK TOTAL KNEE SYSTEM	GMK SPHERIKA FEMORAL COMPONENT S2+R CEMENTED	JWH	MEDACTA INTERNATIONAL SA	02.12.KA12R	2427690	07630345716200

Patients

Seq	Age	Sex	Outcome	Treatment
1