MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Unspecified Musculoskeletal problem (4535); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated as they were not able to be obtained by the rep.Concomitants: 02-020-11-0230 - truliant ps cem fem ps cem left sz 3 sn: (b)(4), 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t sn: (b)(4), 200-02-35 - three peg patella 35mm sn: (b)(4), 204-34-02 - fluted stem extension 25l x 14 mm sn: (b)(4), 204-70-00 - tibial stem ext.Screw sn: (b)(4), recall: z-0023-2022.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 60 yo male patient, who was had an initial left knee replacement on (b)(6) 2018, underwent a revision procedure on (b)(6) 2022, approximately 4 years 5 months post the initial implant procedure.The surgeon revised a size 3 left femur which was loose and ps size 3/9mm insert to a left size 3 constrained condylar femur with a 14x120 stem and a constrained size 3/9mm insert.The patient was last known to be in stable condition following the event.The devices were not able to be obtained by the rep for return.
Additional Manufacturer Narrative
After review of additional information received the primary device is being changed from the insert to the femoral component.The following sections have been updated accordingly for correction: g4- 510k.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the revision reported was likely the result of an insufficient bond between the femoral component and the bone and/or patient-related conditions, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, b5, d1, g2, h6: clinical codes, component code, types of investigation, investigation findings, investigation conclusions.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
Report 1 of 2 for this event.It was reported a patient had an initial left total knee arthroplasty.Subsequently, four (4) years five (5) months later, the patient was revised due to femoral component loosening.The femoral component and tibial insert were revised.The patient was last known to be in stable condition following the event.Additionally, it was reported the patient was revised due to prosthesis wear of the polyethylene component and experiences pain, discomfort, weakness and difficulty walking and standing.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h3, h6, h11 no device was returned for evaluation; photographs of the device were provided; however, the reported event was unable to be confirmed.The review identified the prosthesis wear of the tibial insert could not be confirmed from the provided image, and the device was not returned for evaluation.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of femoral loosening.Additional reasons for the reported revision may be prosthesis wear and inclusion of the polyethylene in the packaging recall.However, the reported prosthesis wear could not be confirmed from the provided information.Potential contributions of user- and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information 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 PS CEM FEM PS CEM LEFT SZ 3
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15438038
• Report Number: 1038671-2022-01128
• Device Sequence Number: 14957614
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/10/2026

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 Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Device Catalogue Number: 02-020-11-0230
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 02/27/2023; 02/28/2023; 01/30/2026; 04/06/2026
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 02/28/2023; 03/13/2023; 02/12/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2018
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 02-022-35-3009 - TRULIANT TIB IMP PS INSERT SZ 3 9.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male