FDA Adverse Event Injury Summary report: N

THREE PEG PATELLA 38MM

MDR report key: 20785285 · Received November 26, 2024

Report

Report Number: 1038671-2024-04512
Event Type: Injury
Date Received: November 26, 2024
Date of Event: August 19, 2024
Report Date: November 26, 2024
Manufacturer: EXACTECH, INC.
Product Code: JWH
UDI-DI: 10885862039613
PMA / PMN Number: K932690
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR, FEMORAL LOOSENING, AND/OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RADIOGRAPHS AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. D10: 4328921 - 02-012-43-5050 - LGC TIBIA RBKTRAY CEM SZ 5F/ 5T; 4893733 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK; 4973207 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; 4973224 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED; 4623398 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS; 06001017117 - A10012 - GPS IMPLANT KIT V2.

Description of Event or Problem · 0

AS REPORTED, APPROXIMATELY 6 YEARS AND 11 MONTHS POST THE INITIAL LEFT TKA, THE PATIENT WAS REVISED AND EVERYTHING REMOVED DUE TO SUSPECTED IMPLANT LOOSENING IN FEMUR AND POLY WEAR/LYSIS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2404108	THREE PEG PATELLA 38MM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.			10885862039613

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male	Hospitalization\| R	SEE H11.