MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 13MM; SEE H10

Model Number	CC TIBIAL INSERT SZ 5, 13MM
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Fluid Discharge (2686); Joint Laxity (4526); Joint effusion (4849)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 59 yo male patient, initial left knee implanted on (b)(6) 2011, who was revised on (b)(6) 2016, underwent a 2nd revision procedure on (b)(6) 2023, approximately 6 years 10 months post the first revision procedure.The patient had pain, recurrent and progressive effusions, and instability.The patient was revised to a 208-25-18 cc tibial insert sz 5 18mm.No device images or x-rays were provided.There were no surgical delays or device breakages reported.The patient was last known to be in stable condition following the event.No device returns anticipated for analysis due to the hospital policy.No further information.The first revision was reported under mdr 1038671-2022-01080.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer d10: concomitants: 200-02-38 - three peg patella 38mm 4463646; 204-04-55 - trapezoid tibial tray sz 5f/5t 4375400; 204-34-04 - fluted stem extension 40l x 14 mm 4537199; 204-36-08 - stem extension 80l x16 mm 4532580; 204-65-88 - tibial augment block 1/2-sz 5 11mm rllm 2296114; 204-65-89 - tibial augment block 1/2-sz 5 11mm llrm 2817235; 208-01-05 - cc femoral sz 5 9854477; 208-07-05 - cc posterior fem augment sz 5, 5mm 2358201; 208-08-05 - cc posterior fem augment sz 5, 10mm 2781671; 208-09-05 - cc stem ext adaptor 5 degree 4286820; 400-40-14 - flex osteotome-flat, nar 4602995; tpa-18 - cement restrictor small ab0070; tpa-24 - cement restrictor large aa9698.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the reported revision due to instability, effusion and reported pain cannot be conclusively determined and the reported event could not be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Instability is a known risk, as outlined in the ifu.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 5, 13MM
• Common Device Name: SEE H10
• 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 ; 3523771140
• MDR Report Key: 17924976
• Report Number: 1038671-2023-02522
• Device Sequence Number: 6773403
• Product Code: JWH
• UDI-Device Identifier: 10885862054425
• UDI-Public: 10885862054425
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2020
• Device Model Number: CC TIBIAL INSERT SZ 5, 13MM
• Device Catalogue Number: 208-25-13
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2015
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male