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

Model Number	02-020-11-0330
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Loss of Range of Motion (2032)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical devices: truliant tibial ps insert size 3, 9mm (cn: 02-022-35-3009, sn: (b)(4)).
Event or Problem Description
As reported, this is the (b)(6) y/o female patient¿s most recent revision occurring approximately 8 months post the femoral revision.This is the 2nd femoral revision due to loosening and lack of motion and pain.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the revision reported was likely the result of either an insufficient bond between the femoral component and the bone, a post traumatic event, multiple previous revision surgeries, or a combination of the three, which led to aseptic (non-infected) femoral loosening, lack of motion, and pain.However, this cannot be confirmed as the explanted devices were not returned for evaluation.Concomitant devices: truliant tibial ps insert size 3, 9mm, cn: (b)(4), sn: (b)(6).No information provided in the following section(s): a4, a5, b6.The following section(s) have additional info: g4, g7, h1, h2, h3, h6 and h7.Section h11: corrections made in the following section(s): (h6) updated codes.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS CEM FEM PS CEM RIGHT SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10560496
• Report Number: 1038671-2020-00540
• Device Sequence Number: 14110278
• Product Code: JWH
• UDI-Device Identifier: 10885862314543
• UDI-Public: 10885862314543
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: No Information
• Device Model Number: 02-020-11-0330
• Device Catalogue Number: 02-020-11-0330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR