MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 2 13MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Legal case - usa.Patient id: (b)(6).As reported via legal documentation, this patient is verified right knee on (b)(6) 2011, then had right knee revision (b)(6) 2023, approximately 12 years after their initial surgery.Post operative report states that the patella was found to be loose with cystic changes underneath the patella.Tibial tray was removed.There is extensive wear in the medial plateau and proximally with tibial post was broken.Femoral and tibial components were extensively evaluated there is no evidence of loosening of either component.Because of this we elected not to revise the femoral and tibial components as there were well fixed.Wound was closed in a layered fashion patient was discharged recovery kept overnight for observation.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.Ebi initial surgery search - hss - no results 02-012-35-2013 - (b)(4) - logic tibia ps mod insrt sz 2 13mm.Serial number (b)(4) is confirmed to have been packaged in a vacuum bag that does not contain evoh.510k: k033883.
Additional Manufacturer Narrative
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 and fracture or due to inclusion of the polyethylene in the packaging recall.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.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 TIBIA PS MOD INSRT SZ 2 13MM
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 16764812
• Report Number: 1038671-2023-00738
• Device Sequence Number: 6034422
• Product Code: JWH
• UDI-Device Identifier: 10885862001740
• UDI-Public: 10885862001740
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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
• Device Expiration Date: 06/01/2017
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 2 13MM
• Device Catalogue Number: 02-012-35-2013
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2009
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female