MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 6; SEE H10

Model Number	02-022-35-6009
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty (b)(6) 2019 and then approximately 3 years, 6 months later experienced a revision surgery on (b)(6)2022.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: 5117448 02-020-11-0260 - truliant ps cem fem ps cem left sz 6.H6.Investigation results: the truliant device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.The patient has bilateral knee replacements.These devices are used for treatment not diagnosis.There is no other information available.
Event or Problem Description
Revision op report on (b)(6) 2022 postoperative diagnosis: failed left knee secondary to aseptic loosening of the femoral component, arthrofibrosis, and recalled polyethylene insert.Healed midshaft left femur fracture with retained retrograde intramedullary nail.The patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
As a result of additional information received, the following fields have been updated: a2, a3, b5, d1, d4, d10, g4, h4, and h6.D10.Concomitants: (b)(6) - truliant ps cem fem ps cem left sz 6 unknown which devices were implanted-left and right devices provided- (b)(6) - truliant tib fit tray cem sz 6f / 5t (b)(6) - advanced patella 35mm 3 peg implant (b)(6) - advanced patella 35mm 3 peg implant h3: investigation results - the reason for the revision is likely the result of a combination of patient conditions and a traumatic injury resulting in pain, stiffness, and mechanical aseptic loosening of the femoral component.Inclusion of the implanted polyethylene in the packaging recall was reported, however, this does not appear to be a factor in the revision as it was documented that no wear was noted on the explanted tibial insert.However, this cannot be confirmed as the devices were not available for evaluation and no images or radiographs were provided.H7 and h9 should be blank.Updated product is not subject to a recall.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 6
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: miguel sosa
• MDR Report Key: 17171697
• Report Number: 1038671-2023-01422
• Device Sequence Number: 20621592
• Product Code: JWH
• UDI-Device Identifier: 10885862314482
• UDI-Public: 10885862314482
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 01/04/2024

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 Model Number: 02-022-35-6009
• Device Catalogue Number: 02-020-11-0260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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.; SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male