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

Model Number	TRULIANT PS POR FEM PS POR LEFT SZ 3.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: truliant posterior stabilized insert size 3.5/12mm (cat# 02-022-35-3512 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 8 months postop the this (b)(6) y/o female patient¿s initial ltka, a revision was completed on a pressfit porous femur.The surgeon thought the femur looked loose and would have to be revised.The pressfit 3.5 femur porous was removed and replaced with a size 3 condylar constrained femur with a 18 x 80 stem.Placed a size 3/17mm ps insert.There were no surgical delays.The patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections d9, g3, g7, h2, h3 and h6 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of of both an insufficient bond between the femoral component and bone and patient conditions, which led to aseptic (non-infected) femoral loosening.The most probable root cause associated with the reported event of "loosening - femoral" is associated with weakened integration of the femoral component at the bone-implant interface due to loss of fibrous and/or bony tissue and leading to compromised anchorage of the device.

• Brand Name: TRULIANT PS POR FEM PS POR LEFT SZ 3.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12329334
• Report Number: 1038671-2021-00390
• Device Sequence Number: 2825703
• Product Code: JWH
• UDI-Device Identifier: 10885862314796
• UDI-Public: 10885862314796
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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 Model Number: TRULIANT PS POR FEM PS POR LEFT SZ 3.5
• Device Catalogue Number: 02-020-12-0235
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 54 YR