MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 22MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-23-22
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Synovitis (2094); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that the patient had a left knee arthroplasty on (b)(6) 2012 and then approximately 10 years later on (b)(6) 2022 had a surgical revision.Revision operative report of 1 dec 2022.Post-operative diagnosis- failed left knee secondary to wear of the bearing surface.Patient was revised to exactech devices.Knee was debrided of exuberant hypertrophic synovial reaction.The femoral, tibial, and patellar components were well fixed.The tibial polyethylene was severely worn with delamination and breakdown of the medial tibial plateau are with severe erosion into the polyethylene post.The patient was awakened and taken to the recovery room in stable condition.No device return.There is no additional information provided/available.
Additional Manufacturer Narrative
D10.Concomitants: 210-01-03-nmc femoral-sn (b)(6) 204-04-33- trapezoid tibial tray sz-sn (b)(6) 200-02-35- three peg patella- sn (b)(6) stryker simplex with tobra these devices are used for treatment not diagnosis.There is no other information available.Pending investigation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (investigation codes).The following sections were corrected: h6 (clinical codes).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: CC TIBIAL INSERT SZ 3, 22MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 19268116
• Report Number: 1038671-2024-01118
• Device Sequence Number: 17980871
• Product Code: JWH
• UDI-Device Identifier: 10885862054296
• UDI-Public: 10885862054296
• 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: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 08/12/2013
• Device Catalogue Number: 208-23-22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2008
• 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: 56 YR
• Patient Sex: Female