MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4.5,10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-51-4510
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant device(s): 5532628 02-020-13-0245 - truliant cr cem fem cr cem left sz 4.5; 5605581 02-022-45-4535 - truliant tib fit tray cem sz 4.5f/3.5t; 5665381 200-07-35 - advanced patella 35mm 3 peg implant; 5972610 201-78-15 - holding pin mini sharp point 4 pk; s013682 521-78-23 - threaded pin size 2.3 collared 2pk; s020030 521-78-32 - threaded pin size 3.0 collarless 2pk; s020045 521-78-32 - threaded pin size 3.0 collarless 2pk; s019042 521-78-36 - threaded pin size 5.1 collarless 2pk; 4043019220 a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 3 years post op the initial tsa, this male patient was revised due to wear on poly and synovitis.Patient was complaining of pain.Patient last known to be in stable condition.Explants unavailable.No other information available.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of the reported prosthesis wear and synovitis, as stated in the experience report.However, this cannot be confirmed as the device was not returned for evaluation and the photographed insert does not appear to show signs of wear that are inconsistent with being implanted for approximately 3.25 years.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.Section h11: *the following sections have corrected information: (h6) component code: 734, bearings.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g reporting contact and reporting contact e-mail, h6 clinical code.
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: b, c, d.The revision reported may have been the result of the reported prosthesis wear and synovitis, as stated in the experience report.However, this cannot be confirmed as the device was not returned for evaluation and the photographed insert does not appear to show signs of wear that are inconsistent with being implanted for approximately 3.25 years.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall 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 4.5,10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 15742757
• Report Number: 1038671-2022-01414
• Device Sequence Number: 5850977
• Product Code: JWH
• UDI-Device Identifier: 10885862312679
• UDI-Public: 10885862312679
• 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: 2019
• 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): 07/14/2025

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: 03/12/2026
• Device Model Number: 02-022-51-4510
• Device Catalogue Number: 02-022-51-4510
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 10/17/2022; 07/11/2025
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 03/21/2023; 12/18/2024; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2018
• 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: Male