MAUDE Adverse Event Report: EXACTECH, INC. TRAPEZOID TIBIAL TRAY SZ 5F/4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRAPEZOID TIBIAL TRAY SZ 5F/4T
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eleven years post initial tka, this (b)(6) male patient had a revision surgery due to the tibial tray was cracked due to asymmetric loading.There was evidence of poly wear, pitting and oxidation and gross wear through poly intraop.Preop, patient had a broken tibial tray with failure of tibia tray in varus and large medial tibial osseolyric defect.The device is not available for evaluation as he requested it and has in his possession.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of a combination of malalignment of the knee in varus and the tibial osteolytic defect on the medial side, which led to asymmetric loading and the tibial tray being unsupported medially, allowing for the tibial tray to fracture.However, this cannot be confirmed because the revised components were not returned to exactech for evaluation.The most probable root cause associated with the reported event of ¿prosthesis fracture¿ is associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.

• Brand Name: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• 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: 13938518
• Report Number: 1038671-2022-00305
• Device Sequence Number: 19986512
• Product Code: JWH
• UDI-Device Identifier: 10885862047717
• UDI-Public: 10885862047717
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: TRAPEZOID TIBIAL TRAY SZ 5F/4T
• Device Catalogue Number: 204-04-54
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: - ACCELERATE CONC. SYS REP BY 620-12-02; - CR TIBIAL INSERT SZ 5, 9MM; - OPTETRAK ASY,CR CEMENTED FEMORAL, SZ 5; - PLATELET RICH PLASMA KIT WITH SPRAY TIPS; - THREE PEG PATELLA 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 109 KG