MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 2, 13MM
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Implant Pain (4561)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 208-22-11 sn# (b)(4) - cc tibial insert sz 2, 11mm - 510k k954208 additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2 years and 8 months post right side tka, this female patient underwent a 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.Updated fields: a2, b2, b5, g, g2, h6 investigation-all.Corrected fields: d10, h6 clinical codes, medical device problem code and component code.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.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: (9940403) 210-01-02 - nmc femoral sz 2.(4552979) 04-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t.(4802546) 204-32-01 - fluted stem extension 11l x 12 mm.(5040489) 200-02-32 - three peg patella 32mm.
Event or Problem Description
It was reported via legal documentation approximately 32 months after a right total knee replacement the patient underwent a revision procedure to address prosthesis wear, pain and right total knee tibial component loosening.A revision operative report was provided.Intraoperatively the surgeon observed clear and golden yellow joint fluid with no signs of purulence.There were synovial fibrillations consistent with wear debris irritation to the medial and lateral gutters.Pathology results came back as non-concerning for infection.The polyethylene insert was removed without incident.The tibial component was noted to be significantly loose.Femoral and patella components were noted to be well fixed.There were cysts medially on the proximal tibia with no significant bone loss.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 and tibial 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 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, 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13416596
• Report Number: 1038671-2022-00107
• Device Sequence Number: 17316165
• Product Code: JWH
• UDI-Device Identifier: 10885862054180
• UDI-Public: 10885862054180
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/25/2025

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: 01/12/2020
• Device Model Number: CC TIBIAL INSERT SZ 2, 13MM
• Device Catalogue Number: 208-22-13
• 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; 09/22/2023; 03/24/2025
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 06/21/2022; 03/17/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female