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

Model Number	LOGIC CR TIB INSERT STD, SZ 2, 13MM
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t 5895759, 02-020-13-0320 - truliant cr cem fem cr cem right sz 2 5815939, 02-022-47-2009 - truliant tib imp cr ins std sz 2, 9mm 5376583, 1400-ag - cemex gento low viscosity 40g kit ab3885, 200-02-35 - three peg patella 35mm 6038558, 204-32-01 - fluted stem extension 11l x 12 mm 5775056, 204-70-00 - tibial stem ext.Screw 6018930.
Event or Problem Description
As reported, the patient had an initial right tka on (b)(6) 2019.The patient was revised due to wear in the liner/tibial components.The tibia, liner and patella were revised to exactech products.There was no surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
H3: the revision reported was most likely due to prosthesis wear.It is possible that a contributing factor to the wear of the tibial insert may have been result of being packaged in a non-conforming vacuum bag for more than five years.However, the prosthesis wear and contributions from implant positioning, instability, and/or patient-related factors to the sequence of events cannot be confirmed as the devices are not available for evaluation and limited clinical information was provided.H7: z-0021-2022.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: h6-clinical codes, medical device problem code and component code.D10: 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t (b)(6), 02-020-13-0320 - truliant cr cem fem cr cem right sz 2 (b)(6), 02-022-47-2009 - truliant tib imp cr ins std sz 2, 9mm (b)(6), 1400-ag - cemex gento low viscosity 40g kit (b)(6), 200-02-35 - three peg patella 35mm (b)(6), 204-32-01 - fluted stem extension 11l x 12 mm (b)(6), 204-70-00 - tibial stem ext.Screw (b)(6).
Event or Problem Description
It was reported via legal documentation that approximately 36 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening.Revision surgery operative notes were provided.Post operative findings noted significantly loose patella and tibial components with bone loss medially and a fractured polyethylene anteromedially and posterolaterally.Intraoperatively it was noted the femur demonstrated it did not appear to be loose.No surgical or medical interventions were reported.No additional information is available.
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, tibial loosening, and patellar 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 STD, SZ 2, 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15426451
• Report Number: 1038671-2022-01121
• Device Sequence Number: 18023099
• Product Code: JWH
• UDI-Device Identifier: 10885862174260
• UDI-Public: 10885862174260
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 08/01/2019
• Device Model Number: LOGIC CR TIB INSERT STD, SZ 2, 13MM
• Device Catalogue Number: 02-012-47-2013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 04/04/2023; 07/17/2023; 03/28/2025
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 04/18/2023; 03/05/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2011
• 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
• 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: 55 YR
• Patient Sex: Female