MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT POR TIB TRAY SIZE 2.5F/2.5T

Model Number	02-022-55-2525
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant devices: truliant psc tibial insert (cn: 02-022-44-2512, sn: (b)(4)).No information provided for age, ethnicity, test dates, and pma/510k #.
Event or Problem Description
Per protocol, exactech total knee components explanted in a right revision total knee procedure were obtained, washed, sterilized, and will be returned to exactech for evaluation.The index right tka procedure was done on (b)(6) 2019.The revision procedure, done on (b)(6) 2019 was undertaken for aseptic loosening of the tibial component ¿02-022-55-2525.During the revision, it was noted that the tibial component did not have bony ingrowth on the medial side; however, some bony ingrowth was appreciated on the underside of the tibial tray, laterally.Therefore, it was necessary to use a small saw to cut through this lateral bony ingrowth, which was done.An exactech tibial extractor was thereafter attached to the tibial tray and with a slap hammer attached was used to extract the tibial tray from the tibia.Exactech cemented tibial components were utilized for the revision, including a 2.5f/1.5t tibial tray, two 5mm, size 1.5 ½-block tibial augments, a 14x120 splined stem, stem extension screw, 29mm tibial cone, and a 2.5, 11mm psc tibial insert.The revision procedure was carried out uneventfully.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision was likely the result of an insufficient bond between the tibial tray and the bone, which led to aseptic (non-infected) tibial loosening.Concomitant device(s): -3 peg patella, 35mm (cn: 200-02-35; sn: (b)(6)) -optetrak logic ps modular tibial insert size 4, 11mm (cn: 02-012-35-4011; sn: unk) -optetrak logic ps femoral component, cemented, left, size 4 (cn: 02-010-01-0240; sn: (b)(6)).

• Brand Name: TRULIANT
• Common Device Name: TRULIANT POR TIB TRAY SIZE 2.5F/2.5T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9195320
• Report Number: 1038671-2019-00518
• Device Sequence Number: 2950120
• Product Code: JWH
• UDI-Device Identifier: 10885862317100
• UDI-Public: 10885862317100
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 02-022-55-2525
• Device Catalogue Number: 02-022-55-2525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 66