FDA Adverse Event Injury Summary report: N

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

MDR report key: 12923765 · Received December 3, 2021

Report

Report Number: 3005180920-2021-00956
Event Type: Injury
Date Received: December 3, 2021
Date of Event: November 10, 2021
Report Date: December 3, 2021
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030825828
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021: LOT 2000484: 70 ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2020. EXPIRATION DATE: 2025-MAY-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 67 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED, BATCH REVIEW PERFORMED ON 11 NOVEMBER 2021: GMK-SPHERE 02.12.0211CRR TIBIAL INSERT FIXED SPHERE CR #2/11 MM R (K181635) LOT 1901348: 60 ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-MAY-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

Description of Event or Problem · 0

THE PATIENT CAME IN REPORTING TIGHTNESS IN THE KNEE AND THE CAUSE OF THE TIGHTNESS IS UNKNOWN. THE SURGEON REVISED THE LINER (WITH A LOWER ONE) AND THE FEMORAL COMPONENT ABOUT 1 YEAR AFTER THE PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE FEMORAL COMPONENT WAS REVISED BECAUSE THE SURGEON WANTED TO USE THE KINEMATIC ALIGNMENT FEMUR ON THIS PATIENT. IT GAVE BETTER LATERAL COVERAGE AND THE PATELLA TRACKED BETTER. SCAR TISSUE WAS PRESENT BUT NOTHING EXCESSIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1823589	GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R	KNEE CEMENTED FEMUR	JWH	MEDACTA INTERNATIONAL SA	02.12.0003R	2000484	07630030825828

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Required Intervention