FDA Adverse Event Injury Summary report: N

GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R

MDR report key: 17169971 · Received June 21, 2023

Report

Report Number: 3005180920-2023-00451
Event Type: Injury
Date Received: June 21, 2023
Date of Event: May 22, 2023
Report Date: June 21, 2023
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630971258006
PMA / PMN Number: K210010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 01-JUN-2023. LOT 2102183: 8. (B)(4) ADDITIONAL DEVICES INVOLVED, BATCH REVIEW PERFORMED ON 01-JUN-2023: GMK-REVISION 02.07.0410SCF FIXED TIBIAL INSERT SC SIZE 4/10MM (K103170) LOT. 185114 LOT 185114: 25 ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2018. EXPIRATION DATE: 2023-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 16 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.4684R TINBN COATED REVISION TIBIAL TRAY SIZE 4 RIGHT (K210010) LOT. 2006119 LOT 2006119: 6 ITEMS MANUFACTURED AND RELEASED ON 15-DEC-2020. EXPIRATION DATE: 2025-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

Description of Event or Problem · 0

AT ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY ALL THE COMPONENTS. THE PRIMARY MEDACTA SURGERY WAS A REVISION OF THE COMPETITOR COMPONENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
207268	GMK-REVISION TINBN COATED FEMUR REVISION PS SIZE 4 R	KNEE FEMUR	JWH	MEDACTA INTERNATIONAL SA	02.07.4404R	2102183	07630971258006

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Required Intervention