FDA Adverse Event Injury Summary report: N

GMK SPHERE TOTAL KNEE SYSTEM

MDR report key: 24710794 · Received March 30, 2026

Report

Report Number: 3005180920-2026-00245
Event Type: Injury
Date Received: March 30, 2026
Date of Event: March 3, 2026
Report Date: March 27, 2026
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030825842
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 10 MARCH 2026: GMK-SPHERE 02.12.0004R GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4R LOT. 2316289 (K121416) LOT 2316289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 2028-10-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.T3I4R GMK-SPHERE TIBIAL COMPONENT CEMENTED T3I4R LOT. 2316356 (K121416) LOT 2316356: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem · 0

AT ABOUT 2 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF A METAL ALLERGY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GMK-SPHERE TO GMK-HINGE TINBN COATED SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
770628	GMK SPHERE TOTAL KNEE SYSTEM	GMK-SPHERE FEMORAL COMPONENT CEMENTED - 4R	JWH	MEDACTA INTERNATIONAL SA	02.12.0004R	2316289	07630030825842

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention