MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 5 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	LOGIC TIBIA PS MOD INSRT SZ 5 13MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Osteolysis (2377); Joint Laxity (4526)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 9 years and 10 months post left side tka, this male patient underwent revision due to aseptic loosening.No additional information is available or forthcoming.The device is not available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.The revision reported was likely the result of an insufficient bond between the implant and the bone, which led to aseptic (non-infected) loosening.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision x-rays were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5, h6 - component code, clinical code, problem code, type of investigation, investigation conclusion.The following sections were corrected: h3 - the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, instability, femoral loosening, and patellar loosening.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.H6 - e code failure of implant no longer applies, problem code loosening of implant not related to bone ingrowth no longer applies, conclusion code known inherent risk of device no longer applies.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
Op report states that the patient presented with a painful and unstable left knee replacement.X-ray demonstrated osteolysis and migration of the femoral component.Mri confirmed this and noted osteolysis and loosening of the patella.There was a very large calcific region lateral to the patella that was visualized on the merchant view that was excised.The liner was removed, and the femoral component was noted to be loose and was removed as well.There was significant fibrous tissue beneath it with osteolysis.Tibial component was also removed.The patient was transferred to the recovery room in stable condition.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.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 5 13MM
• 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: 13418991
• Report Number: 1038671-2022-00119
• Device Sequence Number: 4690796
• Product Code: JWH
• UDI-Device Identifier: 10885862001948
• UDI-Public: 10885862001948
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2025

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: 08/26/2018
• Device Model Number: LOGIC TIBIA PS MOD INSRT SZ 5 13MM
• Device Catalogue Number: 02-012-35-5013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 04/08/2025
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/21/2022; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2010
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male