MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4513
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Synovitis (2094)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 73 y/o male patient's left knee was revised due to the recall, patient was revised to a 4.5/15 mm ps insert.Reason for revision is unknown.Patient was last known to be in stable condition following the event.Devices are not returning, lawyer kept them.X-rays are not available.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): serial #:(b)(6), category #: a10012 - gps implant kit v2, serial #:(b)(6), category #: 200-02-38 - three peg patella 38mm, serial #: (b)(6), category #: 204-70-00 - tibial stem ext.Screw, serial #:(b)(6), category #: 02-020-11-0245 - truliant ps cem fem ps cem left sz 4.5, serial #:(b)(6), category #: 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t, serial #: (b)(6), category #: 02-012-60-1425 - logic stem ext 14mm x 25mm.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and/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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 4.5 13MM
• 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: geoff gannon ; gainesville 32653 ; 3523771140
• MDR Report Key: 16852962
• Report Number: 1038671-2023-00881
• Device Sequence Number: 12403200
• Product Code: JWH
• UDI-Device Identifier: 10885862304568
• UDI-Public: 10885862304568
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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 Expiration Date: 04/11/2026
• Device Catalogue Number: 02-022-35-4513
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 73 YR
• Patient Sex: Male