FDA Adverse Event Injury Summary report: N

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

MDR report key: 9237716 · Received October 25, 2019

Report

Report Number: 3005180920-2019-00900
Event Type: Injury
Date Received: October 25, 2019
Date of Event: October 4, 2018
Report Date: October 25, 2019
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030826139
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 07 OCTOBER 2019: LOT 173757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2017. EXPIRATION DATE: 2022-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: TIBIAL COMPONENT AND INSERT REVISION PERFORMED 1 YEAR AND 8 MONTHS AFTER CEMENTED TOTAL KNEE ARTHROPLASTY. NO INFORMATION CONCERNING PATIENT AGE, ACTIVITY LEVEL AND COMORBIDITIES IS AVAILABLE. ACCORDING TO THE REPORT THE PATIENT WAS COMPLAINING ABOUT INSTABILITY. IN THIS CASES, IT IS THEREFORE COMMON PRACTICE TO RESORT TO A THICKER INSERT AND RECREATE SOFT TISSUE TENSION. THIS SITUATION IS NOT TO BE ASCRIBED TO A MALFUNCTIONING DEVICE.

Description of Event or Problem · 1

THE PATIENT CAME IN COMPLAINING OF MID-FLEXION INSTABILITY. THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE TIBIA, AND CHANGE THE 10MM POLY WITH A 17MM ONE, 1 YEAR AND 7 MONTHS AND A HALF AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1036585	GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L	KNEE TIBIAL INSERT	JWH	MEDACTA INTERNATIONAL SA		173757	07630030826139

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention