MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT TIB IMP PS INSERT SZ 4 13MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this (b)(6) male patient left knee was revised due to swelling and the surgeon changed the insert while in there.The patient was last known to be in stable condition following the event.The device will return.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.(h3) as reported, this 56 y/o male patient left knee was revised; however, the reason is unknown.The patient was last known to be in stable condition following the event.The device will return.Additional information received indicates that the patient had a revision due to swelling and the surgeon changed the insert while in there.Upon review of the available information, there is no evidence that this is a device related problem and no allegation against the device.Implantation of a total joint could result pain, infection, loosening of total joint hardware and the patient should monitor their activity and stresses to the operated knee.The most likely cause of the reported event is patient¿s conditions.Section d9: device available for evaluation (d9) the device was not returned to manufacturer for evaluation.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11346315
• Report Number: 1038671-2021-00054
• Device Sequence Number: 14660529
• Product Code: JWH
• UDI-Device Identifier: 10885862304476
• UDI-Public: 10885862304476
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2024
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 4 13MM
• Device Catalogue Number: 02-022-35-4013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 56 YR