MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-4009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 6599612, 02-020-13-0240 - truliant cr cem fem cr cem left sz 4.6646776, 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.6757114, 201-78-15 - holding pin mini sharp point 4 pk.6737472, 201-78-98 - 2 pk, schanz pin, 4mm x 130mm.5340625, 521-78-23 - threaded pin size 2.3 collared 2pk.S20580, 521-78-32 - threaded pin size 3.0 collarless 2pk.S205806, 521-78-32 - threaded pin size 3.0 collarless 2pk.1069721010, a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 2 years post op the initial tka, this male patient was revised due wear.Surgeon noted some wear on the posterior medial edge, replaced poly and resurfacing the patella.He released the pcl.He stated that there was a good chance the patella was causing pain so he resurfaced the patella.The original surgery he left the patella alone.Explant not available, hospital does not release to the reps.Patient left in stable condition.
Additional Manufacturer Narrative
(h3) the revision reported may have been the result of the pain due to not resurfacing the patella during the initial surgery.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the tibial insert was not returned for (h6) component code: 734, bearings.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4, 9MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16477933
• Report Number: 1038671-2023-00336
• Device Sequence Number: 14234537
• Product Code: JWH
• 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: 2021
• Device Explanted Year: 2023
• 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): 09/10/2026

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 Expiration Date: 08/29/2025
• Device Catalogue Number: 02-022-51-4009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 09/10/2026
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 08/10/2023; 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown