MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 5; SEE H10

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 02-020-11-0350 - truliant ps cem fem ps cem right sz 5 5615294; 02-022-35-5009 - truliant tib imp ps insert sz 5 9mm 5354557 - recall device; 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t 5216674; 200-07-35 - advanced patella 35mm 3 peg implant 5450993.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 58 yo male patient, initial right knee implanted on (b)(6) 2018, underwent a revision procedure on (b)(6) 2023, approximately 4 years 4 months post the initial procedure.The patient complained of pain.Loose femur and recalled poly indicated.The patient was revised to a competitor¿s devices.The event was not related to a breakage of device.There were no surgical delays.The patient was last known to be in stable condition following the event.No patient history or comorbidities were reported.No x-rays were provided.A device image was provided.No device returns anticipated.Due to the recall, the hospital will not release implants.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of patellar prosthesis wear or the reported femoral loosening.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed.Possible causes for polyethylene wear include the alleged femoral loosening, third body wear, patient-related conditions, or any combination of these possibilities.As the suspect device was not provided, these potential causes or their contribution to the sequence of events cannot be confirmed.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 RIGHT SZ 5
• Common Device Name: SEE H10
• 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: kate jacobson ; 3523771140
• MDR Report Key: 16753149
• Report Number: 1038671-2023-00704
• Device Sequence Number: 8627419
• Product Code: JWH
• UDI-Device Identifier: 10885862314581
• UDI-Public: 10885862314581
• 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: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 PS CEM FEM PS CEM RIGHT SZ 5
• Device Catalogue Number: 02-020-11-0350
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• 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
• 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 Age: 58 YR
• Patient Sex: Male