MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-44-1009
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/12/2019
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) 2015, a (b)(6) y/o, female patient with a bmi of 34.2, underwent implantation of a insert tib 1 11mm knee post stab cnstrn and insert tib 1 9mm knee post stab cnstrn.On (b)(6) 2019, approximately 47 months post implant, the patient underwent revision due to aseptic loosening.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g4, g7, h2 and h3 have been updated accordingly.(h3) the evaluation noted that revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening of the tibial tray and/or femoral component.However, this cannot be confirmed as the devices were not available for evaluation.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2020-00393 and 1038671-2020-00394.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 1, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10382237
• Report Number: 1038671-2020-00394
• Device Sequence Number: 3529186
• Product Code: JWH
• UDI-Device Identifier: 10885862173393
• UDI-Public: 10885862173393
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/24/2020

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: 02-012-44-1009
• Device Catalogue Number: 02-012-44-1009
• Device Lot Number: UNKNONW
• 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: 09/09/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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: 70 YR