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

Model Number	02-022-51-4510
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 5354779 02-020-13-0245 - truliant cr cem fem cr cem left sz 4.5, 6634352 02-022-45-4535 - truliant tib fit tray cem sz 4.5f/3.5t, 6547741 200-02-35 - three peg patella 35mm, 6684565 201-78-15 - holding pin mini sharp point 4 pk, 6737477 201-78-98 - 2 pk, schanz pin, 4mm x 130mm, s128837 521-78-23 - threaded pin size 2.3 collared 2pk, s116074 521-78-32 - threaded pin size 3.0 collarless 2pk, s116076 521-78-32 - threaded pin size 3.0 collarless 2pk.Pending investigation.
Event or Problem Description
Per a report from the legal department a 64 y/o female patient had a left knee replacement on (b)(6) 2020.Approximately 1 years and 5 months after the initial procedure the patient had a left knee revision on (b)(6) 2022.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report: (b)(6) 2023/ (b)(6) rec'd via legal 11 apr 2023.Diagnosis: failed left polyethylene component sterile dressing was applied and the patient was transported to the recovery room.
Additional Manufacturer Narrative
H3.Investigation results-the truliant tib imp crc insert device with sn (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The most likely cause of the subsequent revision appears to have been the polyethylene insert recall.Per the revision operative report, the surgeon did not note that there were any problems with the device or conditions with the patient related to the device.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
The patient presented to the surgeon for an exchange due to the device recall.There is no mention of any other conditions pre-revision procedure.The polyethylene component was removed and "it was intact".There are no other intraoperative conditions mentioned.The patient was revised to an exactech device.Sterile dressing was applied and the patient was transported to the recovery room.The patient was discharged from the hospital on (b)(6) 2022.No additional information.
Event or Problem Description
As reported a female patient had a left knee replacement.Approximately 1 years and 5 months after the initial procedure the patient had a left knee revision.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following corrections have been made: b1, b2, b5, e4, (remove data from initial), g1, g2, h6: clinical code, component code, types of investigation.The most likely cause of the subsequent revision appears to have been the polyethylene insert recall.Per the revision operative report, the surgeon did not note that there were any problems with the device or conditions with the patient related to the device.These devices are used for treatment not diagnosis.There is no other information available.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, CEMENTED, POLYMER/METAL/POLYMER
• 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: geoff gannon ; 3523771140
• MDR Report Key: 16844026
• Report Number: 1038671-2023-00871
• Device Sequence Number: 6861051
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2026

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: 02-022-51-4510
• Device Catalogue Number: 02-022-51-4510
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 02/23/2026
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 09/25/2023; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female