MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT PS CEM FEM PS CEM LEFT SZ 4
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately five years post initial left tka, the 54 y/o male patient complained of pain.The patient had a revision due to loose femur and insert.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images and x-rays attached.The devices are not available for evaluation due to chain of command.
Additional Manufacturer Narrative
Section d10: concomitant products: truliant tib imp ps insert sz 4 9mm (cat# 02-022-35-4009 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Revision surgery operative notes were provided.Preoperative and postoperative diagnoses indicated left knee polyethylene wear, loose femur, recalled implant.Findings: loose femur, catastrophic polyethylene delamination.Indications: based on history, physical examination, imaging and laboratory values, this patient has a recalled left total knee arthroplasty with polyethylene bearing failure and femoral loosening that is now recalcitrant to conservative measures.Description of procedure: the polyethylene was removed with half-inch osteotome.A thorough synovectomy was performed and the gutters were re-established.The back of the knee was debrided.The knee was flexed.Quarter-inch osteotome was used to disrupt the cement implant interface around the femoral component.While doing this, it was clear that the femoral component was completely loose.It was easily extracted without any residual cement on the component.The implant bone interface was established around the tibial component.An attempt was made to extract the tibial component, which appeared to be well fixed.A saw blade was used to remove the patellar component which demonstrated some delamination.The patient was revised to same mfg devices.The patient was awakened from anesthesia and taken to the pacu having tolerated the procedure well.The patient arrived in the pacu in stable condition with no apparent complications.No additional information is available.
Additional Manufacturer Narrative
Corrected information: h6 - health effect code new information: b4.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 4
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19472465
• Report Number: 1038671-2024-01776
• Device Sequence Number: 3566183
• Product Code: JWH
• UDI-Device Identifier: 10885862314451
• UDI-Public: 10885862314451
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2025

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 Model Number: TRULIANT PS CEM FEM PS CEM LEFT SZ 4
• Device Catalogue Number: 02-020-11-0240
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 04/09/2025
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/14/2024; 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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: THREE PEG PATELLA 38MM.; TRULIANT TIB FIT TRAY CEM SZ 4F / 4T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 153 KG