MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; TRULIANT PS POR FEM PS POR RIGHT SZ 2.5

Model Number	TRULIANT PS NAFEM PS POR RIGHT SZ 2.5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation pending.Concomitant devices: truliant tibial psc insert size 2.5, 11mm(cat# 02-022-44-2511.Sn# (b)(4)).Stem extension screw.(cat# 204-70-00, sn# (b)(4)) (this implant was removed from the patient on (b)(6) 2020 and inadvertently thrown away).No information provided in the following section(s): ethnicity, and implant date.
Event or Problem Description
As reported, this (b)(6) female was initially implanted with a right tka on 7/8/2019.A tibial component revision on (b)(6) 2019.Currently, approximately 6 months postop the initial implant, the patient is having her femoral components revised due to aseptic loosing of the porous-ingrowth femoral component.It was noted that the femoral component was loose to a manual push test.A locking femoral impactor was attached to the femoral component on the bone and a slap hammer was attached to the impactor.With only a few strikes of the slap hammer, the femoral component came off the bone.The surgeon noted that there was no bony ingrowth on the femoral component; there was only the presence of fibrous tissue that was adhering the implant to the bone.The patient's femur was prepped to accept an exactech cc femoral component.A logic right size 2 cc femoral component with 14x120 was cemented into place.A size 2f-2.5t x 15mm transition tibial insert was also implanted and found to be stable.The spine stiffening screw was seated, and the procedure was otherwise completed without incident.No other implants were removed during this procedure.The patient left the or in stable condition.Devices will be returned except for stem extension screw.(b)(4) (this implant was removed from the patient on (b)(6) 2020 and inadvertently thrown away).Patient medical history of non-smoker; normal bmi and non-drinker.Patient¿s weight is (b)(6).All available information has been received at this time.
Additional Manufacturer Narrative
The evaluation noted in the revision reported was likely the result of an insufficient bond between the femoral component and bone, which led to aseptic (non-infected) femoral loosening.(d11) concomitant devices: truliant tibial psc insert size 2.5, 11mm cat# 02-022-44-2511.Sn# (b)(6).Stem extension screw.Cat# 204-70-00, sn# (b)(6) this implant was removed from the patient on (b)(6) 2020 and inadvertently thrown away.

• Brand Name: TRULIANT
• Common Device Name: TRULIANT PS POR FEM PS POR RIGHT SZ 2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9666006
• Report Number: 1038671-2020-00020
• Device Sequence Number: 11548824
• Product Code: JWH
• UDI-Device Identifier: 10885862314888
• UDI-Public: 10885862314888
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: TRULIANT PS NAFEM PS POR RIGHT SZ 2.5
• Device Catalogue Number: 02-020-12-0325
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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: 66 YR
• Patient Weight: 67