FDA Adverse Event Injury Summary report: N

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L

MDR report key: 10198975 · Received June 26, 2020

Report

Report Number: 3005180920-2020-00357
Event Type: Injury
Date Received: June 26, 2020
Date of Event: May 27, 2020
Report Date: June 26, 2020
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030826771
PMA / PMN Number: K121416
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BATCH REVIEW PERFORMED ON 06 JUNE 2020: LOT 1904545: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2019. EXPIRATION DATE: 2024-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0025L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L (K140826) LOT. 1903624. BATCH REVIEW PERFORMED ON 08 JUNE 2020: LOT 1903624: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AGO-2019. EXPIRATION DATE: 2024-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

Description of Event or Problem · 1

THE PATIENT CAME IN REPORTING AN INABILITY TO ACHIEVE FULL EXTENSION AFTER HEARING A POPPING SOUND DURING REHAB. 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, RESECTED MORE THE DISTAL FEMUR AND REVISED THE INSERT TO A THINNER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON OF POPPING SOUND IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
666203	GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L	FIXED TIBIAL INSERT	JWH	MEDACTA INTERNATIONAL SA	02.12.0512FL	1904545	07630030826771

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention