MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported.Approximately two years post initial right side tka, female patient complained of pain.Patient had a revision and synovitis and wear on poly was found.Patient last known to be in stable condition.The devices are not available for evaluation.
Additional Manufacturer Narrative
Concomitants products: truliant cr cem fem cr cem right sz 2.5 (cat# 02-020-13-0325 / serial# (b)(4)); truliant tib fit tray cem sz 2.5f / 2.5t (cat# 02-022-45-2525 / serial# (b)(4)); holding pin mini sharp point 4 pk (cat# 201-78-15 / serial# (b)(4)); threaded pin size 2.3 collared 2pk (cat# 521-78-23 / serial# (b)(4)); threaded pin size 3.0 collarless 2pk (cat# 521-78-32 / serial# (b)(4)); threaded pin size 5.1 collarless 2pk (cat# 521-78-36 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the reason for the pain and synovitis leading to the revision reported cannot be determined from the information provided but does not appear to be related to prosthesis wear as the provided images appear unremarkable.However, this cannot be confirmed as the devices were not returned for evaluation.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.The most probable root cause associated with the reported event of ¿prosthesis wear¿ is associated with material damage to a surface, usually involving progressive loss or displacement of material, due to relative motion between that surface and a contacting substance or substances.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d8, e4 (remove erroneous entry from initial report), h6: clinical codes, component code, investigation findings and investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 2.5,10MM
• 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15632979
• Report Number: 1038671-2022-01330
• Device Sequence Number: 20323640
• Product Code: JWH
• UDI-Device Identifier: 10885862312556
• UDI-Public: 10885862312556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2026

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 CRC INSERT SZ 2.5,10MM
• Device Catalogue Number: 02-022-51-2510
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 03/11/2026
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 03/21/2023; 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GPS IMPLANT KIT V2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female