MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 4, 11MM
Medical Device Problem Codes	Peeled/Delaminated (1454); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal, that this patient's right knee was implanted (b)(6) 2005; revision date: (b)(6) 2019.Reason for the revision was not reported.No additional information provided.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.H7: z-0019-2022.
Additional Manufacturer Narrative
G3/g4: date was accidentally left off on follow-up #1.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation, investigation findings).The following sections were corrected: d1 (brand name).D4 (expiration date).H6 (health effect - clinical code, medical device problem code).The reason for the revision reported cannot be determined from the available information but may have been reported at this later time due to inclusion of one of the implanted devices in the packaging recall.However, the reported prosthesis wear/failure could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as no images or radiographs were provided, relevant clinical information was not provided, and the devices were not available for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 170 months after a right total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, discomfort, swelling, synovium and osteolysis.Revision surgery operative notes were provided.Summary of the findings at the time of surgery examination demonstrates intact stability.Arthroscopic inspection demonstrates no signs of infection.Small particulate of the polyethylene insert was observed with some pitting and wear on the post.The polyethylene insert was explanted a new insert implanted.There was a ganglion cyst posterior laterally that was likely the cause of the perceived focal swelling in that area.All components were well fixed with no loosening.
Additional Manufacturer Narrative
Corrected fields: a2-3, b1-2, d1, d4, d8, d10, g contact name and email, g2, g4, h4 and h6: clinical codes, medical device problem codes and component codes.D10: (b)(6) 204-04-43 - trapezoid tibial tray sz 4f/3t, (b)(6) 200-02-35 - three peg patella 35mm, (b)(6) 210-01-04 - nmc femoral sz 4, (b)(6) 204-43-89 - tibial augment block 1/3-sz 3 11mm llrm, (b)(6) 204-34-08 - fluted stem extension 80l x 14 mm.

• Brand Name: CC TIBIAL INSERT SZ 4, 9MM
• 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: 15331666
• Report Number: 1038671-2022-00987
• Device Sequence Number: 15187822
• Product Code: JWH
• UDI-Device Identifier: 10885862054326
• UDI-Public: 10885862054326
• 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: 2005
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 03/13/2010
• Device Model Number: CC TIBIAL INSERT SZ 4, 11MM
• Device Catalogue Number: 208-24-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 09/07/2022; Not provided; 12/20/2024
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 09/27/2022; 10/06/2022; 12/04/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2005
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male