MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT PS CEM FEM PS CEM RIGHT SZ 4

Model Number	02-020-11-0340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: (cn: 02-022-35-4009, sn:(b)(4)) truliant tibial ps insert size 4 9mm.
Event or Problem Description
As reported, approximately 26 months after a (b)(6) y/o male patient¿s initial right tka procedure, the knee was revised for instability.During the revision, the patient¿s femoral component was found grossly loose.The component was removed and there was no cement adhesion was on the backside of the femoral component.We revised to a size 4 cc femur with a 40mm cemented stem.The ps poly was increased from a 9mm to a 11mm ps insert.All other components (tibia and patella) were stable.The surgeon had mentioned that the patient had recent fall/impact on the knee in question.The date of this incident is unknown.Patient was last known to be in stable condition following the event.Device to return.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision was was likely the result of either an insufficient bond between the femoral component and the bone, a post traumatic event, or a combination of the two, which led to aseptic (non-infected) femoral loosening and instability.Concomitant devices: (cn: 02-022-35-4009, sn: (b)(6)) truliant tibial ps insert size 4 9mm.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10551703
• Report Number: 1038671-2020-00524
• Device Sequence Number: 2444797
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 02-020-11-0340
• Device Catalogue Number: 02-020-11-0340
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/02/2020
• 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
• Patient Age: 71 YR