MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	11/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 61 y/o male patient had a left knee replacement on (b)(6) 2017.Approximately 5 years and 6 months after the initial procedure the patient had a left knee revision on (b)(6) 2022 due to effusion and discomfort.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2022.Diagnosis: failed left knee with polyethylene wear there was no metallosis or purulence present with the synovial fluid and no evidence of impingement of the metallic implant cement and the metallic implants were deemed competent.The patient was awoken and transferred to recovery room in stable condition.No complications occurred throughout the case.
Additional Manufacturer Narrative
D10: concomitants: 4441672 02-010-03-0250 - logic cr femoral cem, left, sz 5, 4738235 02-012-45-5050 - lgc tibial fit tray cem sz 5f / 5t, and 4161344 200-02-38 - three peg patella 38mm.Pending investigation.
Additional Manufacturer Narrative
Recall number: z-0021-2022.1038671-2025-00019 this follow-up report is being submitted to relay additional and/or corrected information.The product associated with the reported event is within the scope of recall z-0021-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-00019.D10: concomitants: 4441672 02-010-03-0250 - logic cr femoral cem, left, sz 5; 4738235 02-012-45-5050 - lgc tibial fit tray cem sz 5f/5t; 4161344 200-02-38 - three peg patella 38 mm.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17096815
• Report Number: 1038671-2023-01299
• Device Sequence Number: 13936164
• Product Code: JWH
• UDI-Device Identifier: 10885862174598
• UDI-Public: 10885862174598
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 11/30/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 5, 11MM
• Device Catalogue Number: 02-012-48-5011
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2013
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male