MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP PS INSERT SZ 4 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - three peg patella 38mm (cat# 200-02-38).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, surgeon made the indication during revision knee arthroplasty and has requested that the explanted items be sent to manufacturer to study the nature of which the implants have failed.Poly insert exchange (15 ps size 4) and 38 patella.There was breakage of a device.There were no parts or pieces fell into the patient wound.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The devices will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, surgeon made the indication during revision knee arthroplasty and has requested that the explanted items be sent to manufacturer to study the nature of which the implants have failed.Poly insert exchange (15 ps size 4) and 38 patella.There was breakage of a device.There were no no parts or pieces fell into the patient wound.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the subsequent revision cannot be conclusively determined, reason not reported.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14823495
• Report Number: 1038671-2022-00718
• Device Sequence Number: 17296380
• Product Code: JWH
• UDI-Device Identifier: 10885862304490
• UDI-Public: 10885862304490
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 4 15MM
• Device Catalogue Number: 02-022-35-4015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown