MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	02-022-35-2009
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 02-012-60-1425, logic stem ext 14mm x 25mm, 5626824, 02-020-11-0220, truliant ps cem fem ps cem left sz 2, 4876787, 02-022-45-2020, truliant tib fit tray cem sz 2f / 2t, 4750300, 200-07-32, advanced patella 32mm 3 peg implant, 5724067, 204-70-00, tibial stem ext.Screw, 5721095.
Event or Problem Description
As reported, approximately 3.5 years post op the initial tsa, this 70 y/o female patient was revised due to aseptic femoral loosening and recalled polyethylene insert.The case report form indicates this event is definitely related to devices and procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: h3: the femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation, pre-revision x-rays were unable to be obtained, and potential contributions from the type of cement used, cementing technique, or environmental conditions in the operating room at the time of implantation cannot be determined from the provided information.Patient-related conditions and/or inclusion of the implanted polyethylene in the packaging recall may also have been contributing factors to the revision.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: a, c, d, e, g.The femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation, pre-revision x-rays were unable to be obtained, and potential contributions from the type of cement used, cementing technique, or environmental conditions in the operating room at the time of implantation cannot be determined from the provided information.Patient-related conditions and/or inclusion of the implanted polyethylene in the packaging recall may also have been contributing factors to the revision.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 9MM
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16064131
• Report Number: 1038671-2022-01635
• Device Sequence Number: 2009815
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2025

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 Expiration Date: 08/30/2025
• Device Model Number: 02-022-35-2009
• Device Catalogue Number: 02-022-35-2009
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 10/11/2023; 01/22/2025
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 11/02/2023; 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• 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
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White