MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	02-022-44-3009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, this 60 year old, 107 kg., male patient had a left tha on (b)(6) 2020.The patient was revised due to poly wear.There is no reported breakage of the device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending product evaluation.Concomitant medical products: 02-020-11-0230 truliant ps cem fem ps cem left sz 3 6086134, 02-022-45-3020 truliant tib fit tray cem sz 3f / 2t 6219482, 200-02-35 three peg patella 35mm 6187931.
Additional Manufacturer Narrative
New information received 2/3/2023: as per legal notification, the patient had an initial left tka on 3/12/2020.Imaging studies revealed ¿synovitis¿ to which is consistent with ¿reaction to polyethylene polymeric debris.¿ due to worsening pain, instability, and a ¿persistent pain and swelling,¿ the patient underwent left knee replacement revision surgery on (b)(6) 2022.During the revision surgery, the patient's orthopedic surgeon identified ¿moderate synovitis with pseudomembrane formation¿related to polyethylene wear¿ and noted ¿wear of the polyethylene insert on the medial aspect as well as on the post of the knee.¿ upon information and belief, the loose components and significant synovitis were due to premature polyethylene wear of the tibial insert.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of third body wear, patient related conditions, or a combination of these possibilities.An additional contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.However, this cannot be confirmed as the device was not returned for evaluation.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3, 9MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15051248
• Report Number: 1038671-2022-00806
• Device Sequence Number: 4822269
• Product Code: JWH
• UDI-Device Identifier: 10885862305077
• UDI-Public: 10885862305077
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 02-022-44-3009
• Device Catalogue Number: 02-022-44-3009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 12/02/2022; 02/03/2023
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 02/02/2023; 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 107 KG