MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 2, 11MM, SLOPE ++; SEE H10

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Osteolysis (2377); Implant Pain (4561)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal notification, that patient, underwent initial left knee replacement surgery on (b)(6) 2011 and was implanted with a optetrak device.Plaintiff underwent a left knee revision surgery on (b)(6) 2018, approximately 7 years 4 months post initial procedure and was implanted with a different device.Plaintiff continues to experience pain and discomfort on a daily basis in both of her knees which limits her daily activities and quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
Additional information received by the legal department on 19 feb 2023: dob: (b)(6) 1961 preoperative diagnosis: osteoarthritis left knee revision for left total knee arthroplasty preoperative diagnosis- failed left total knee secondary to osteolysis.Femoral, tibial, and patellar component.The patient presented to the office secondary to underlying osteolysis of her left knee.She had continued instability and pain secondary to failure of conservative management.¿osteolysis on radiograph was not evident within the bone grossly.There is no grafting or areas of cavitation to fill with graft sleeves were elected to be used secondary to the diffuse osteolysis noted on radiography and for added stability.¿ the patient was reversed from anesthesia and taken to pacu in stable condition.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
As a result of additional information received, the following fields have been updated: d1, d4, d10, g4, h4, h7, and h9.H6: investigation results - the revision reported was likely the result of osteolysis and prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the osteolysis and prosthesis wear could not be determined 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: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16378015
• Report Number: 1038671-2023-00168
• Device Sequence Number: 17711884
• Product Code: JWH
• UDI-Device Identifier: 10885862041227
• UDI-Public: 10885862041227
• 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: 2011
• Device Explanted Year: 2018
• 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,Followup
• Report Date (Section B): 11/14/2023

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: 12/21/2013
• Device Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 200-72-11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 02/19/2023; 11/06/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/27/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2008
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female