MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-5015
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
On (b)(6) 2018, a (b)(6) y/o, male patient with a bmi of 42.8, underwent implantation of a insert truliant tibia impt pssz 5 15mm.On (b)(6) 2019, approximately 6 months post implant, the patient underwent revision due to instability.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g4, g7, h2 and h3 have been updated accordingly.(h3) upon review of all available information, there is no evidence to suggest that a design or manufacturing issue caused or contributed to this event.The reported revision was likely the result of underlying patient factors, which led to instability of the joint.Per ifu# 700-096-004 instability is a known complication following total knee replacement surgery and is multifactorial in nature.Instability is listed as a potential adverse event associated with total joint replacement surgery in the product ifu (700-096-004).As noted in why are total knee arthroplasties failing today¿has anything changed after 10 years? (sharkey, p.L.(2014s, september).The journal of arthroplasty, 29), instability is in the top five reasons for that account for approximately 85% of total knee revisions (7.35% of revisions are for instability).

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 5 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10382812
• Report Number: 1038671-2020-00402
• Device Sequence Number: 3529190
• Product Code: JWH
• UDI-Device Identifier: 10885862304674
• UDI-Public: 10885862304674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-022-35-5015
• Device Catalogue Number: 02-022-35-5015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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; Disability
• Patient Age: 49 YR