MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 11MM, SLOPE ++; SEE H10

Model Number	200-73-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemoral, semi-constrained, cemented, polymer/metal/polymer.D10.Concomitants: aa2260 13a2101 - cemex system fast genta 70g.1351125 200-02-35 - three peg patella 35mm.1338355 200-04-33 - cemented finned tib.Tra sz 3f/3t.1219705 201-78-14 - holding pin headless sharp point long 4pk.1227631 201-78-15 - holding pin mini sharp point 4 pk.6c100 203-96-01 - (11-2222) saw blade new stryk (.050).78108 203-96-21 - (11-2714) stryker 2000 90x13/21x 1.9mm.1325690 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Aa1362 asa0030 - sterile disposable containers.This revision was initially reported under mfr# 1038671-2015-00220 in 2015, this event is entered into the electronic complaint handling system for processing ease and to comply with current sops.These devices are used for treatment not diagnosis.Pending investigation.There is no other information available.
Event or Problem Description
It was reported via legal documentation that a patient had an initial right total knee arthroplasty on (b)(6) 2008 and approximately 6 years, 4 months later experienced a revision surgical procedure on (b)(6) 2015.It is stated that the patient has suffered the following injuries and complications as a result of the device: joint pain, joint swelling and stiffness, tissue damage, revision surgery, polyethylene wear, & constrained liner revision.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
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.However, the reported prosthesis wear could not be confirmed and potential contributions of user, or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: CR TIBIAL INSERT SZ 3, 11MM, 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: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 17332253
• Report Number: 1038671-2023-01671
• Device Sequence Number: 7361338
• Product Code: JWH
• UDI-Device Identifier: 10885862041265
• UDI-Public: 10885862041265
• 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: 2008
• Device Explanted Year: 2015
• 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): 01/07/2025

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: 03/19/2013
• Device Model Number: 200-73-11
• Device Catalogue Number: 200-73-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 01/07/2025
• Date Device Manufactured: 03/20/2008
• 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