MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-49-2013
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this female patient had another revision on her left knee.Reason for the revision was not reported.Previous revision for left knee was captured in 1038671-2022-00758 / (b)(4).
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined; no reason was given.Section h11: *the following sections have corrected information: (b5) as reported by legal that this female patient underwent the second revision surgery to remove the optetrak that had been implanted in her left knee an orthopedic surgeon and replace it with another prosthesis.No additional information.
Event or Problem Description
As reported by legal that this female patient underwent the second revision surgery to remove the optetrak that had been implanted in her left knee an orthopedic surgeon and replace it with another prosthesis.No additional information.
Additional Manufacturer Narrative
As a result of additional information, the following fields have been updated: d1, d4, d10, g4, h4, and h6.D10.Concomitants: 200-02-35 - three peg patella 35mm sn: (b)(6).H3: investigation results - the revision reported was likely the result of prosthesis wear and osteolysis.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.Additionally, a contributing factor to the reported wear may have been the result of being packaged in a non-conforming vacuum bag for more than five years.The extent and root cause of the prosthesis wear and osteolysis could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: LOGIC CR TIB INSERT SLOPE++, SZ 2, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 3523771140
• MDR Report Key: 14943406
• Report Number: 1038671-2022-00759
• Device Sequence Number: 6196082
• Product Code: JWH
• UDI-Device Identifier: 10885862174338
• UDI-Public: 10885862174338
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2024

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 Expiration Date: 11/15/2019
• Device Catalogue Number: 02-012-49-2013
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 01/09/2024
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/15/2022; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2011
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female