MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	CR TIBIAL INSERT SZ3, 15MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6)2012.Approximately 10 years and 8 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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 right knee.There was a large non bloody effusion and extensive synovitis throughout the entire knee.There was gross polyethylene wear on the tibial insert and flakes of polyethylene scattered throughout the knee.Patellar component was in good condition with no substantial wear.The femoral and tibial components were each removed with minimal iatrogenic bone loss.On the femoral side there was substantial osteolysis with near complete loss of both posterior condyles and extensive anterior bone loss under the femoral flange.
Additional Manufacturer Narrative
D10: concomitants: 2143691, 02-012-45-3040 - lgc tibial fit tray cem sz 3f / 4t.2223162, 200-02-32 - three peg patella 32mm.1961297, 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Pending investigation.
Additional Manufacturer Narrative
Recall number: z-0019-2022 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-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.D10: concomitants: (b)(6) 02-012-45-3040 - lgc tibial fit tray cem sz 3f / 4t.(b)(6) 200-02-32 - three peg patella 32mm.(b)(6) 230-03-03 - optetrak asy,cr cemented femoral, sz 3.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.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: CR TIBIAL INSERT SZ3, 15MM
• 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: 17539586
• Report Number: 1038671-2023-01933
• Device Sequence Number: 6303463
• Product Code: JWH
• UDI-Device Identifier: 10885862040275
• UDI-Public: 10885862040275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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: 09/07/2018
• Device Model Number: CR TIBIAL INSERT SZ3, 15MM
• Device Catalogue Number: 200-23-15
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2010
• 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: 75 YR
• Patient Sex: Male