MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number	TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
Medical Device Problem Codes	Mechanical Problem (1384); Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant medical products: logic fit/rbk augment 1/2 block rl/lm sz5 10mm (cat# 02-012-50-5014 / serial# (b)(4).Tru fluted stm ext 18mm x 80mm blast (cat# 02-012-64-1880 / (b)(4).Logic cc femoral size 4, left (cat# 02-010-06-0240 / serial# (b)(4).Three peg patella 35mm (cat# 200-02-35 / serial# (b)(4).Tru fluted stm ext 16mm x 80mm blast (cat# 02-012-64-1680 / serial# (b)(4).Truliant tib fit tray cem sz 4f / 5t (cat# 02-022-45-4050 / serial# 5738793) tibial stem ext.Screw (cat# 204-70-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal team, approximately 4.1 years post initial left tka, the 59 year old male patient had a revision due to premature poly wear and poly recall with osteolysis and loosening of the femoral and tibial components.During revision surgery, it was found to be a clean wound with clear synovial joint fluid.There were found to be grossly loose femoral and tibial components that were easily removed with a bone tamp.There was also found to be a well-fixed patellar button.There was a moderate amount of polyethylene wear, both visibly and palpable on the tibial polyethylene component.There was encapsulated polyethylene debris within the synovium and a complete synovectomy was performed.Patient was revised to competitors devices.The patient was awakened and transferred to recovery in stable condition.The devices are not available for evaluation.
Additional Manufacturer Narrative
H6: corrected the following: health effect - clinical code, impact code, medical devices problem code, component code, type of investigation, investigation findings, investigation conclusions.The reason the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, tibial loosening, femoral loosening, loss of range of motion (mechanical problem) or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16696863
• Report Number: 1038671-2023-00602
• Device Sequence Number: 3677379
• Product Code: JWH
• UDI-Device Identifier: 10885862305299
• UDI-Public: 10885862305299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 Expiration Date: 01/19/2026
• Device Model Number: TRULIANT TIB IMP PSC INSERT SZ 4, 12MM
• Device Catalogue Number: 02-022-44-4012
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2018
• 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: GPS IMPLANT KIT V2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male