MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT PS CEM FEM PS CEM LEFT SZ 2

Model Number	02-020-11-0220
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: ps insert (cn: 02-022-35-2009; sn: (b)(4)).
Event or Problem Description
As reported, this (b)(6) y/o female patient approximately 1.5 years postop the initial implant complained of pain.A bone scan was performed which determined that the femoral component was loose.During the revision, the femoral component was removed by hand with no cement adhered to the femoral component.The poly insert clearly showed pitting.Also, osteolysis was present in the femur.Revised the femur with a size 2 cc femoral component with an offset and 40mm cemented stem.The poly was also replaced with a 2 x 13mm ps insert.Patient was last known to be in stable condition following the event.The devices were disposed of by the facility.
Additional Manufacturer Narrative
(h3) the evaluation noted that the revision reported was likely the result of a combination of aseptic loosening between the femoral component and the bone and prosthesis wear.The loosening may have led to an increase in cement and bone particles in the joint space and resulted in prosthesis wear or prosthesis wear may have contributed to particle-induced osteolysis.However, the contribution of loosening and prosthesis wear to the sequence of events cannot be determined as the devices were not available for evaluation.(d11) concomitant devices: ps insert (cn: 02-022-35-2009; sn: (b)(6)).

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS CEM FEM PS CEM LEFT SZ 2
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9848979
• Report Number: 1038671-2020-00249
• Device Sequence Number: 10944388
• Product Code: JWH
• UDI-Device Identifier: 10885862314413
• UDI-Public: 10885862314413
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 02-020-11-0220
• Device Catalogue Number: 02-020-11-0220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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: 50 YR