MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3012
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	11/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: 201-78-89 - 3" drill bit, mod.Hex 2 pack, (b)(6).02-020-11-0230 - truliant ps cem fem ps cem left sz 3, (b)(6).201-78-89 - 3" drill bit, mod.Hex 2 pack, (b)(6).200-03-32 - one peg patella 32mm, (b)(6).201-78-15 - holding pin mini sharp point 4 pk, (b)(6).02-022-45-3030 - truliant tib fit tray cem sz 3f / 3t, (b)(6).521-78-23 - threaded pin size 2.3 collared 2pk, (b)(6).
Event or Problem Description
As reported, approximately 2 years and 10 months post the initial left total knee arthroplasty, the patient was revised due to swelling, pain, and instability.The indications for revision were not subject to only potential poly wear.The patient was revised to a 17mm psc poly.The femoral and tibial components were deemed stable and were not revised.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3 12MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20928785
• Report Number: 1038671-2024-04828
• Device Sequence Number: 8320061
• Product Code: JWH
• UDI-Device Identifier: 10885862304285
• UDI-Public: 10885862304285
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-3012
• 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: 11/25/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 06/05/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female