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

Model Number	TRULIANT TIB IMP PS INSERT SZ 2 9MM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patello femorotibial, semi-constrained, cemented, polymer/metal/polymer.D10: concomitants: 02-020-11-0220 - truliant ps cem fem ps cem left sz 2, (b)(6).02-022-45-2020 - truliant tib fit tray cem sz 2f / 2t, (b)(6).200-07-29 - advanced patella 29m 3 peg implant, (b)(6).201-78-15 - holding pin mini sharp point 4 pk, (b)(6).201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack, (b)(6).521-78-23 - threaded pin size 2.3 collared 2pk, (b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk, (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported a 55 yo female patient, initial left 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 presented to the surgeon with pain.A loose femur and recalled poly were indicated.The patient was revised to a competitor¿s devices.There were no device breakages or surgical delays reported.The patient was last known to be in stable condition following the event.A device image and an x-ray were provided.No patient history or comorbidities known.The device is not available for return, due to the recall, the hospital will not release it.No further information.
Additional Manufacturer Narrative
H3: 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 secondary to contributions from patient-related conditions.However, this failure mode cannot be confirmed as the devices were not available for evaluation and the view on the provided radiograph was inconclusive.Inclusion of the implanted polyethylene in the packaging recall may also have been a contributing factor to the 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: 17586584
• Report Number: 1038671-2023-01997
• Device Sequence Number: 4801634
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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 Expiration Date: 02/09/2025
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2 9MM
• Device Catalogue Number: 02-022-35-2009
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female