MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0250
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.(b)(6) 02-020-11-0250 - truliant ps cem fem ps cem left sz 5.(b)(6) 02-012-60-1440 - logic stem ext 14mm x 40mm.(b)(6) 204-70-00 - tibial stem ext.Screw.(b)(6) 200-07-32 - advanced patella 32mm 3 peg implant.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 review of manufacturing data was performed and no discrepancies relevant to the reported event were found.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have been the result of prosthesis wear and femoral loosening as stated in the operative notes.The femoral loosening may have been the result of failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.However, this cannot be confirmed as there were no details regarding cementing technique or environmental conditions provided.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the reported polyethylene wear cannot be determined as the devices were not available for evaluation, and pre-revision radiographs and images of the explanted devices were 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
As reported via legal documentation, a patient had left knee replacement surgery due to advanced degenerative joint disease, left knee, varus deformity, flexion contracture.They were subsequently revised, approximately 3 months post primary procedure.Revision op report states that the patient indicated for surgery due to pain, instability, and swelling.The report further states that the loosening of the femoral component was noted.Femoral component had no fixation to the cement, but cement had a good fixation to-the bone.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.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 5
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: katy priest ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25217291
• Report Number: 1038671-2026-00617
• Device Sequence Number: 10001688
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 Catalogue Number: 02-020-11-0250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 05/19/2026
• Date Device Manufactured: 01/11/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male