FDA Adverse Event Injury Summary report: N

GMK SPHERE TOTAL KNEE SYSTEM

MDR report key: 20630839 · Received November 7, 2024

Report

Report Number: 3005180920-2024-00939
Event Type: Injury
Date Received: November 7, 2024
Date of Event: October 11, 2024
Report Date: November 7, 2024
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630971261280
PMA / PMN Number: K202022
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 07-NOV-2024: LOT 2338886: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2023. EXPIRATION DATE: 2028-09-24. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07-NOV-2024: GMK-SPHERIKA 02.12.KA11R FEMORAL COMPONENT SPHERIKA CEMENTED S1+R (K211004) LOT 2315337: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2023. EXPIRATION DATE: 2028-08-28. 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.

Description of Event or Problem · 0

AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT REPORTED PAIN DUE TO ADHESION AND SCAR TISSUE FORMATION AS WELL AS PATELLA DISCOMFORT. HAS BEEN ALSO REPORTED PRESENCE OF INSTABILITY. THE SURGEON REVISED THE FEMUR AND INSERT AND RESURFACED THE PATIENT'S NATURAL PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1598429	GMK SPHERE TOTAL KNEE SYSTEM	GMK-SPHERIKA TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM R E-CROSS	JWH	MEDACTA INTERNATIONAL SA	02.12.E0210FR	2338886	07630971261280

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention