MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT PS CEM FEM PS CEM LEFT SZ 3

Model Number	02-020-11-0230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tibial ps insert (cn: unkown, sn: unknown) pending engineering evaluation.
Event or Problem Description
The patient complained of pain.The surgeon planned to do a synevectomy and poly swap to address patient complaint of pain.Following synevectomy and removal of poly the surgeon utilized a bone tamp to ensure the implants were stable.The femoral component was loose and came off easily with no cement adhesion to the prosthesis.Following removal, cement was removed from distal femur.The femur was then prepared utilizing traditional instrumentation (distal clean up cut, 4 in 1 block, trial placed, and ps box prepared).A primary size 3 femoral component was then implanted utilizing palacos cement.The patient left the operating room with a well-balanced total knee replacement.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the femoral component and subsequent pain.However, this cannot be confirmed because the component was not returned for evaluation.Concomitant device(s): - truliant tibial ps insert (cn: unkown, sn: unknown).Corrections made, patient is male and not female.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9185113
• Report Number: 1038671-2019-00515
• Device Sequence Number: 2950479
• Product Code: JWH
• UDI-Device Identifier: 10885862314437
• UDI-Public: 10885862314437
• Combination Product (Y/N): N
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 02-020-11-0230
• Device Catalogue Number: 02-020-11-0230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/15/2020
• 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