MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; SEE H10

Model Number	TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 4777849 02-022-35-3011 - truliant tib imp ps insert sz 3 11mm.***serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.4736629 02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t.4847377 200-07-32 - advanced patella 32mm 3 peg implant.4907017 204-34-02 - fluted stem extension 25l x 14 mm.4909664 204-70-00 - tibial stem ext.Screw.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 66 yo female patient, initial right knee implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2023, approximately 5 years 11 months post the initial procedure.The patient complained of pain.A loose femur and recalled poly were indicated for the revision procedure.The patient was revised to a competitor¿s devices.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No device returns anticipated, due the recall, the hospital will not release them.An x-ray and device images were provided.No additional patient details or history provided.No further information.
Additional Manufacturer Narrative
The femoral loosening reported is most likely the result of either a weakened biologic integration of the femoral component at the bone-implant interface or mechanical loss of fixation at the cement-implant interface.However, the failure cannot be confirmed as the device was not returned for investigation and loosening or femoral positioning issues could not be confirmed on the provided ap radiograph.Inclusion of the implanted polyethylene tibial insert in the packaging recall may have been a contributing factor to the reported revision.

• Brand Name: TRULIANT
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17126330
• Report Number: 1038671-2023-01340
• Device Sequence Number: 15311959
• Product Code: JWH
• UDI-Device Identifier: 10885862314543
• UDI-Public: 10885862314543
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• 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): 11/08/2023

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: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
• Device Catalogue Number: 02-020-11-0330
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female