FDA Adverse Event Injury Summary report: N

GMK HINGE TOTAL KNEE SYSTEM

MDR report key: 21476355 · Received February 27, 2025

Report

Report Number: 3005180920-2025-00129
Event Type: Injury
Date Received: February 27, 2025
Date of Event: February 3, 2025
Report Date: February 27, 2025
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: KRO
PMA / PMN Number: K130299
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 10 FEBRUARY 2025: LOT 2200974: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2022. EXPIRATION DATE: 2027-05-12. 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 IMPLANT REVISED. BATCH REVIEW PERFORMED ON 10 FEBRUARY 2025 ON GMK-HINGE 02.09.HE12 GMK-HINGE HINGE POST EXTENSION 12 MM -TINBN COATED (K210010) LOT. 2214929. LOT 2214929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JUL-2022. EXPIRATION DATE: 2027-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem · 0

THE PATIENT HAD A LACK OF RANGE OF MOTION IN THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON PERFORMED A SYNOVECTOMY AND REVISED THE POLY AND HINGE POST. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
698215	GMK HINGE TOTAL KNEE SYSTEM	KNEE FIXED TIBIAL INSERT	KRO	MEDACTA INTERNATIONAL SA	02.09.0312H	2200974

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR	Female	Required Intervention