FDA Adverse Event Injury Summary report: N

GMK TOTAL KNEE SYSTEM

MDR report key: 24494900 · Received March 3, 2026

Report

Report Number: 3005180920-2026-00190
Event Type: Injury
Date Received: March 3, 2026
Date of Event: January 29, 2026
Report Date: March 3, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630345716248
PMA / PMN Number: K211004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 12 FEBRUARY 2026. GMK-SPHERIKA 02.12. KA14R GMK SPHERIKA FEMORAL COMPONENT S4+R CEMENTED (K211004) LOT 2402430: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2024. EXPIRATION DATE: 25-JUN-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 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 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A LOOSE FEMORAL IMPLANT AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED THAT THE BONE QUALITY WAS GOOD AND THERE WERE NO SIGNS OF INFECTION. ADDITIONALLY, THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO A COMPETITOR TRAY, INSERT, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
558420	GMK TOTAL KNEE SYSTEM	GMK SPHERIKA FEMORAL COMPONENT S4+R CEMENTED	JWH	MEDACTA INTERNATIONAL SA	02.12.KA14R	2402430	07630345716248

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention