FDA Adverse Event Injury Summary report: N

TRULIANT TIB IMP PSC INSERT SZ 6, 15MM

MDR report key: 20189463 · Received September 11, 2024

Report

Report Number: 1038671-2024-03440
Event Type: Injury
Date Received: September 11, 2024
Date of Event: December 1, 2023
Report Date: September 11, 2024
Manufacturer: EXACTECH, INC.
Product Code: JWH
UDI-DI: 10885862305602
PMA / PMN Number: K152170
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem · 0

LEGAL CASE ¿ USA (MDL NO. (B)(6)). RELATED CASE-2022-00005226 LK REV 1. IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 28 MONTHS AFTER A LEFT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEAR, PAIN, STIFFNESS, DISCOMFORT, AFFECTED MOBILITY. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(6), 02-022-44-6015 - TRULIANT TIB IMP PSC INSERT SZ 6, 15MM: SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES CONTAIN EVOH AND WAS NOT AFFECTED BY THE RECALL. 510K: K152170.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1537198	TRULIANT TIB IMP PSC INSERT SZ 6, 15MM	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	EXACTECH, INC.		UNK	10885862305602

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male