MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-012-44-2515
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/24/2019
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, male patient with a bmi of 31.6, underwent implantation of a insert tib 2.5 15mm knee poststab cnstr.On (b)(6) 2019, approximately 49 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.However, this cannot be confirmed since the devices were not returned for evaluation.
Additional Manufacturer Narrative
H10.Additional/updated information-d4.Expiration date 19 sep 2021, d8, h4 (b)(6) 2013, h6 health effect - impact code, type of investigation, investigation findings, investigation conclusions, h7, h9.These devices are used for treatment not diagnosis.

• Brand Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 2.5, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 10382053
• Report Number: 1038671-2020-00391
• Device Sequence Number: 3529184
• Product Code: JWH
• UDI-Device Identifier: 10885862173546
• UDI-Public: 10885862173546
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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 Expiration Date: 09/19/2021
• Device Model Number: 02-012-44-2515
• Device Catalogue Number: 02-012-44-2515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/11/2020; 11/27/2023
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/24/2020; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0021-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male