MAUDE Adverse Event Report: EXACTECH, INC. LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation a 60 y/o patient had a left knee replacement on (b)(6)2018.Approximately 4 years and 10 months after the initial procedure the patient had a left knee revision on (b)(6) 2023 due to pain.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) 2023: diagnosis: failed left knee arthroplasty the femoral component was grossly loose and removed.At this time, the tibial polyethylene was noted to be broken and was removed.The tibia was grossly loose and removed.The patella was worn and removed.The patient tolerated the procedure well.
Additional Manufacturer Narrative
D10: concomitants: 4876814, 02-010-03-0230 - logic cr femoral cem, left, sz 3.5155720 02-012-45-3030 - lgc tibial fit tray cem sz 3f / 3t.Ab2027, 1400-ig - cemex genta high viscosity 40g kit.5383828, 200-02-35 - three peg patella 35mm.5370096, 204-32-01 - fluted stem extension 11l x 12 mm.5399997, 204-70-00 - tibial stem ext.Screw.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, fracture, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.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.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 3, 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: kate jacobson ; 3523771140
• MDR Report Key: 17090174
• Report Number: 1038671-2023-01294
• Device Sequence Number: 16845414
• Product Code: JWH
• UDI-Device Identifier: 10885862174390
• UDI-Public: 10885862174390
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• 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): 01/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM
• Device Catalogue Number: 02-012-48-3011
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown