MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 15MM; PROSTHESIS, KNEE, PATELLO FEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	N/A
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Emotional Changes (1831); Bone Fracture(s) (1870); Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	12/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6)2019.Following the surgery, the patient began experiencing increasing pain, instability, aching, popping, stiffness, buckling, weakness, and swelling to her knees.In (b)(6) 2021, the patient was descending a set of stairs when her knees gave out.She fell down the stairs.Several months later, the patient suffered another fall due to weakness in her knees.On (b)(6) 2023, the patient reported that the pain, weakness, and popping in her knees had become increasingly worse over the past year.The patient's physician explained that due to ¿one of the packaging layers of the plastic insert¿ being ¿out of specification,¿ early oxidation ¿can cause the plastic to wear out earlier than expected or to become damaged after it is implanted.¿ with the patient's continued symptoms of knee pain, swelling, and the inability to bear weight, plaintiff agreed to undergo a right knee revision surgery followed by a left knee revision surgery.Plaintiff will undergo a left total knee replacement revision surgery to remove the device from her left knee.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The following sections were updated: a2, a3, d6b.D10 concomitant devices: (b)(6) 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t, (b)(6) 200-07-29 - advanced patella 29m 3 peg implant, e1, g1, h6.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, and femoral loosening 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 and radiographs 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 TIB IMP PS INSERT SZ 2.5 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLO FEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17002993
• Report Number: 1038671-2023-01141
• Device Sequence Number: 12407147
• Product Code: JWH
• UDI-Device Identifier: 10885862304223
• UDI-Public: 10885862304223
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 02-022-35-2515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female