MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR INS SLOPE+ SZ 3.5 9 MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-48-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); Implant Pain (4561); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6), 02-020-13-0235 - truliant cr cem fem cr cem left sz 3.5; (b)(6), 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t; (b)(6), 200-02-32 - three peg patella 32mm.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 32 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, inflammation, local muscular atrophy, excessive fluid buildup causing swelling, implant failure, pain, disabling complications, and permanent alteration of gait.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear, implant component loosening, and/or due to the inclusion of the polyethylene in the packaging recall.However, this cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and no photos, radiographs, or relevant clinical information was provided.H6: corrected health effect and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CR INS SLOPE+ SZ 3.5 9 MM
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20894488
• Report Number: 1038671-2024-04740
• Device Sequence Number: 15714278
• Product Code: JWH
• UDI-Device Identifier: 10885862306852
• UDI-Public: 10885862306852
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Catalogue Number: 02-022-48-3509
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 01/18/2018
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male