MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	TRULIANT TIB IMP PSC INSERT SZ 3, 17MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 6256569, 02-020-11-0330 - truliant ps cem fem ps cem right sz 3.5938314, 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.5886528, 200-07-29 - advanced patella 29m 3 peg implant.6359429, 201-78-15 - holding pin mini sharp point 4 pk.718883, 203-96-51 - stryker kms2212f.M62 90x13/22x1.19mm.S046983, 521-78-23 - threaded pin size 2.3 collared 2pk.S048030, 521-78-31 - threaded pin size 2.6 collarless 2pk.Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2020.Approximately 2 years and 7 months after the initial procedure the patient had a right knee revision on (b)(6) 2022 due to instability, pain and lack of mobility.The clinical findings and diagnoses as a result of the revision surgery are consistent with the defects of the exactech knee system.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, e, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and loosening.Or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were 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 PSC INSERT SZ 3, 17MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16895029
• Report Number: 1038671-2023-00947
• Device Sequence Number: 14975213
• Product Code: JWH
• UDI-Device Identifier: 10885862305145
• UDI-Public: 10885862305145
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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 Model Number: TRULIANT TIB IMP PSC INSERT SZ 3, 17MM
• Device Catalogue Number: 02-022-44-3017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: Not provided; 01/14/2025
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/30/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• 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