MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	200-72-11
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: asymmetric cr femoral component (230-03-02, 2113689); trapezoidal tibial tray (204-04-22, 2068372); patella (200-02-35, 2123341); exactech cemex bone fast track (1510/s, aa4681).Pending investigation.
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2011.Approximately 5 years and 10 months after the initial procedure the patient had a right knee revision on (b)(6) 2017 with competitors products.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2017 diagnosis: complete polyethylene failure with metal on metal articulation metallosis staining of the synovium.They then did a subtotal synovectomy taking out all tissue around the synovium that was dark and blackened as much as was reasonable due to being around either ligamentous structures or neurovascular structures.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of prosthesis wear of the posterior medial aspect of the tibial insert.This may be related to excessive overall posterior tibial slope of the tibial insert.The extent and root cause of this prosthesis wear could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• 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: miguel sosa ; 3523771140
• MDR Report Key: 17875425
• Report Number: 1038671-2023-02456
• Device Sequence Number: 7095329
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/18/2013
• Device Catalogue Number: 200-72-11
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2008
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female