MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial tka on (b)(6) 2020.The patient showed up to the clinic with pain and synovitis.The patient was revised on (b)(6) 2022.Laxity was noted.There was some pitting and surface changes noted on the insert.The patient was stable and had good rom.A new insert was implanted.The patient left in stable condition.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-020-13-0235 - truliant cr cem fem cr cem left sz 3.5 sn: (b)(4), 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t sn: (b)(4), 200-02-35 - three peg patella 35mm sn: (b)(4), 201-78-15 - holding pin mini sharp point 4 pk sn: (b)(4), 521-78-23 - threaded pin size 2.3 collared 2pk sn: (b)(4), 521-78-32 - threaded pin size 3.0 collarless 2pk sn: (b)(4), 521-78-32 - threaded pin size 3.0 collarless 2pk sn: (b)(4), 521-78-36 - threaded pin size 5.1 collarless 2pk sn: (b)(4), a10012 - gps implant kit v2 sn: (b)(4).
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The patient has bilateral knee replacements, this suggests joint maladies.The cause of the subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s condition.H7: z-0023-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported may have been due to prosthesis wear, and/or instability.However, the reported instability could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information was not provided.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 3.5, 11MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15349005
• Report Number: 1038671-2022-01024
• Device Sequence Number: 20140560
• Product Code: JWH
• UDI-Device Identifier: 10885862307705
• UDI-Public: 10885862307705
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 10/09/2025
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
• Device Catalogue Number: 02-022-51-3511
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/11/2022; 06/25/2024; 07/09/2025
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/29/2022; 01/03/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female