MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CC TIBIAL INSERT SZ 2, 11MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Distress (2329); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10 concomitants: (b)(6), 208-01-02 - cc femoral sz 2.(b)(6), 204-30-08 - stem extension 80l x10 mm.(b)(6), 200-03-32 - one peg patella 32mm.(b)(6), 208-09-05 - cc stem ext adaptor 5 degree.(b)(6), 204-32-08 - stem extension 80l x12 mm.(b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.
Event or Problem Description
Legal case ¿ usa.Patient id: (b)(6).(b)(4).Additional information received from legal on 14-nov-2023.4 jan 2024, v simms, rn - implant date: (b)(6) 2016- revision op report attached.Explant date: (b)(6) 2021, revision op report attached- the devices were implanted for approximately 4 years, 6 months.Post operative diagnosis: mechanical loosening.Revision of all components to zimmer persona revision system.Upon opening the knee joint, the femoral component was noted to be grossly loose and this was easily extracted by hand.Similarly, the patellar component was totally loose and easily pried off of the remaining patellar bone stock.Sterile dressings were applied and the patient was extubated in stable condition.Original description summary as reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.Approximately 6 years and 6 months after the initial procedure the patient had the first left knee revision on (b)(6) 2016.Approximately 6 months after the first left knee revision the patient had a second left knee revision on (b)(6) 2017.After each of the left total knee replacement surgeries, the patient began to suffer from symptoms, including but not limited so synovitis with aseptic loosening, mechanical loosening, pain and lack of mobility.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.The device, cc tibial insert serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.Approximately 6 years and 6 months after the initial procedure the patient had the first left knee revision on (b)(6) 2016.Approximately 6 months after the first left knee revision the patient had a second left knee revision on (b)(6) 2017.After each of the left total knee replacement surgeries, plaintiff began to suffer from symptoms associated with the defects of exactech knee system as alleged in this complaint, including but not limited so synovitis with aseptic loosening, mechanical loosening, pain and lack of mobility.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
B4: corrected.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The device, is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 2, 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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
• MDR Report Key: 21232434
• Report Number: 1038671-2025-00397
• Device Sequence Number: 11833918
• Product Code: JWH
• UDI-Device Identifier: 10885862054173
• UDI-Public: 10885862054173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 01/07/2017
• Device Model Number: CC TIBIAL INSERT SZ 2, 11MM
• Device Catalogue Number: 208-22-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 02/03/2025; 05/16/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/03/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2012
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female