MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-020-11-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that this patient had an initial left total knee arthroplasty on (b)(6) 2019 and then approximately 3 years, 4 months, after initial implant, underwent a left knee revision for femoral loosening.Operative report of (b)(6) 2023-revision of left knee failed total knee arthroplasty due to loosening.Implant recall.Operative findings- loose femoral component with debonding of the metal/cement interface.Well fixed tibial component.Chronic synovitis of the knee.No complications.Patient presented to the clinic with ongoing left knee pain.Dressings were placed and the patient was revived from anesthetic.Patient to be discharged to home when all criteria are met.¿all components removed were handed off for chain of custody per patients request.¿ there is no other patient demographic or medical history available.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: serial #: (b)(6), category #: 02-029-99-1002 - threaded head pin 2.3" square head, serial #: (b)(6), category #: 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack, serial #: (b)(6), category #: 200-02-32 - three peg patella 32mm, serial #: (b)(6), category #: 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t, serial #: (b)(6), category #: 521-78-36 - threaded pin size 5.1 collarless 2pk.
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: b, c, d, e, g the reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear 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 PS CEM FEM PS CEM LEFT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: kate jacobson ; 3523782617
• MDR Report Key: 16879715
• Report Number: 1038671-2023-00917
• Device Sequence Number: 14882475
• Product Code: JWH
• UDI-Device Identifier: 10885862314444
• UDI-Public: 10885862314444
• 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: 2019
• 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): 01/14/2025

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
• Device Model Number: 02-020-11-0235
• Device Catalogue Number: 02-020-11-0235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2019
• 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
• 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: 66 YR
• Patient Sex: Female