MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3511
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Joint Laxity (4526)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10.D10.Concomitants: 7248, 203-96-67 - fan sawblade ez2213f.M63 90x22 1.27mm strkr 5/6/7.5673547, 02-020-12-0335 - truliant ps por fem ps por right sz 3.5.6030527, 02-022-55-3525 - truliant por tib tray size 3.5f/2.5t.6118996, 201-78-89 - 3" drill bit, mod.Hex 2 pack.6557098, 200-02-32 - three peg patella 32mm.6715429, 201-78-15 - holding pin mini sharp point 4 pk.S012816, 180-65-45 - alteon 6.5mm screw, 45mm.S034476, 180-65-45 - alteon 6.5mm screw, 45mm.S089300, 521-78-31 - threaded pin size 2.6 collarless 2pk.S099112, 521-78-23 - threaded pin size 2.3 collared 2pk.These devices are used for treatment not diagnosis.Pending investigation.
Event or Problem Description
It was reported via legal documentation that a patient had a total right knee arthroplasty on (b)(6) 2020 and then approximately 3 years 1 month later experienced a revision surgical procedure on (b)(6) 2023.Revision operative report of (b)(6) 2023- postoperative diagnosis: mechanical failure right total knee arthroplasty with instability procedure performed: revision right total knee arthroplasty femoral and tibial components.Patient revised to competitor's devices.Findings: no clinical evidence of infection, histological analysis demonstrated no acute inflammation, ligamentous and flexion instability, predominantly laterally, well fixed femoral, tibial, and patellar components, poly wear with gross instability.The patient was awakened and sent to the recovery room in stable condition.There were no complications.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 following sections were updated: d1, d2a, d2b, g3, g4, h6 the following sections were corrected: h6 mdr section codes updated/corrected: a, b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and instability 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 3.5 11MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19018749
• Report Number: 1038671-2024-00710
• Device Sequence Number: 15438592
• Product Code: JWH
• UDI-Device Identifier: 10885862304360
• UDI-Public: 10885862304360
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02-022-35-3511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female