MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: logic cr femoral cem, left, sz 5 (cat# 02-010-03-0250 / serial# (b)(4)); lgc tibial fit tray cem sz 5f / 4t (cat# 02-012-45-5040 / serial# (b)(4)); three peg patella 35mm (cat# 200-02-35 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal team, approximately three years post initial tka, this (b)(6)male patient indicates that patient was diagnosed with mechanical failure.Patient underwent revision surgery due to significant polyethylene wear and cystic formation within the proximal tibia and the distal femur.Following the revision surgery, patient continues to be limited in activities of daily living, patient has difficulty with daily activities such as getting dressed, climbing stairs, and bathing.Furthermore, despite undergoing the revision surgery, patient experiences daily pain and discomfort in left knee which limits patient¿s activities of daily living and impacts patient quality of life.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
The revision reported in the case was likely the result of prosthesis wear of the tibial insert, possibly due to malalignment between the implants, high contact stresses during knee flexion and/or extension, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, the type, extent, and cause of the prosthesis wear cannot be determined because the revised components were not returned for evaluation and no radiographs or photographs were provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: 14212599
• Report Number: 1038671-2022-00471
• Device Sequence Number: 19910922
• Product Code: JWH
• UDI-Device Identifier: 10885862174581
• UDI-Public: 10885862174581
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2023

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: 11/09/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 5, 9MM
• Device Catalogue Number: 02-012-48-5009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2022; 04/06/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/27/2023; 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• 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: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male