MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR LEFT SZ 4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,

Model Number	02-020-12-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this 58 year old, male patient had a left initial tka on (b)(6) 2020.The press fit femoral component showed loose on a bone scan and the patient was revised on (b)(6)2022.The patient was revised to a constrained size 4 left side and a size 4/13mm ps liner with a 18x80 cemented stem.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: truliant tibia insert ps size 4 13mm - cn: 02-022-35-4013 / sn: (b)(4).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.As reported, this male patient had a left initial tka.The press fit femoral component showed loose on a bone scan and the patient was revised.The patient was revised to a constrained size 4 left side and a size 4/13mm ps liner with a 18x80 cemented stem.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.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 POR FEM PS POR LEFT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS,
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15174864
• Report Number: 1038671-2022-00887
• Device Sequence Number: 6213087
• Product Code: MBH
• UDI-Device Identifier: 10885862314802
• UDI-Public: 10885862314802
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02-020-12-0240
• Device Catalogue Number: 02-020-12-0240
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male