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

Catalog Number	02-020-11-0230
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 66 y/o female patient's left knee was revised approximately 4 years and 11 months post op.Patient complained of pain.Loose femur and recalled poly.Due to recall surgeon used competitor for revision.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H3: pending investigation.D10: 4953636 02-022-44-3009 - truliant tib imp psc insert sz 3, 9mm m010077 02-022-35-3009 - truliant tib imp ps insert sz 3 9mm 5605227 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t 5788111 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t 360341 02-029-99-1001 - fluted headless pin 3.0" square head 5448789 200-07-32 - advanced patella 32mm 3 peg implant 5611461 200-07-32 - advanced patella 32mm 3 peg implant.(it is unknown which is right or left).H7: z-0023-2022 for 4953636 02-022-44-3009 - truliant tib imp psc insert sz 3, 9mm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images 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, POLYMER/METAL
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19244002
• Report Number: 1038671-2024-01051
• Device Sequence Number: 20570175
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• 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
• Report Date (Section B): 03/13/2025

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 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: 04/10/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 107 KG