MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE +; SEE H10

Model Number	200-63-09
Medical Device Problem Codes	Material Integrity Problem (2978); Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received by the legal department on 28 feb 2023: on (b)(6) 2012, the patient underwent a right total knee replacement with an exactech knee device.On (b)(6) 2017, approximately 5 years later the patient underwent revision of the right exactech knee device secondary to significant polyethylene liner wear with resulting metallosis, osteolysis, and synovitis.It is also stated that despite undergoing the revision surgery, the patient experiences daily knee pain and discomfort which limit activities of daily living and recreation and impacts quality of life.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
Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2350164 200-02-35 - three peg patella 35mm; 2199224 204-04-33 - trapezoid tibial tray sz 3f/3t; 1304943 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Follow up type: initial and fu1 fda mdr reported under mfr# 1038671-2017-00535, this is being filed, with additional information and this is from a historical case before electronic complaint handling system.
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, femoral loosening, and tibial loosening or due to inclusion of the polyethylene in the packaging recall.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: CR TIBIAL INSERT SZ 3, 9MM, SLOPE +
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16617465
• Report Number: 1038671-2023-00513
• Device Sequence Number: 6093573
• Product Code: JWH
• UDI-Device Identifier: 10885862041067
• UDI-Public: 10885862041067
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• 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): 02/06/2025

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: 12/28/2013
• Device Model Number: 200-63-09
• Device Catalogue Number: 200-63-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2008
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown