FDA Adverse Event Injury Summary report: N

GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

MDR report key: 18063840 · Received November 3, 2023

Report

Report Number: 3005180920-2023-00835
Event Type: Injury
Date Received: November 3, 2023
Date of Event: October 5, 2023
Report Date: November 3, 2023
Manufacturer: MEDACTA INTERNATIONAL SA
Product Code: JWH
UDI-DI: 07630030819872
PMA / PMN Number: K090988
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

BATCH REVIEW PERFORMED ON 6 OCTOBER 2023: LOT 2001520: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2020. EXPIRATION DATE: 2025-JUL-03. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR ON 2 NOVEMBER 2023: AT 2.5 YEARS AFTER PRIMARY CEMENTED TKA THE TIBIAL TRAY IS FOUND LOOSE AND NEEDS REVISION. FROM THE RADIOGRAPH ATTACHED, A RATHER THICK CEMENT MANTLE IS VISIBLE UNDERNEATH THE TRAY, SOMETHING THAT COULD HAPPEN, FOR INSTANCE, IF THE CEMENT CURED FASTER THAN EXPECTED, OR THE TRAY WAS IMPACTED LATER: IN THESE CONDITIONS, THE INTERDIGITATION OF THE CEMENT IN THE METAL STRUCTURE IS SUBOPTIMAL AND LOOSENING IS A POSSIBLE CONSEQUENCE. WE CANNOT STATE WITH CERTAINTY THAT THIS WAS THE ROOT CAUSE FOR REVISION, BUT WE THINK, BASED ON EXPERIENCE, THAT IT'S A GOOD POSSIBILITY.

Description of Event or Problem · 0

ABOUT 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, TIBIAL TRAY AND INSERT REVISED DUE TO TIBIAL TRAY LOOSENING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2111921	GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R	KNEE TIBIAL INSERT	JWH	MEDACTA INTERNATIONAL SA		2001520	07630030819872

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR	Female	Required Intervention