MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-23-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: the cc tibial insert with serial number: (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported via legal documentation that a patient had a left total knee arthroplasty first revision on (b)(6) 2015, and then experienced second revision surgical procedure on (b)(6) 2017 approximately 1 year and 8 months after first revision implant.No images were provided.There is no other information available.
Event or Problem Description
Revision operative report of 10 jul 2017- irrigation and debridement knee liner exchange - wound class: clean left.Diagnosis: left knee acute periprosthetic infection.The patient was awoken from anesthesia without incident trans-the pacu in stable condition.Post-operative plan: the patient be allowed to weight-bear as tolerated.He will receive perioperative antibiotics and be started on dvt prophylaxis.He will be discharged home from the hospital when they are comfortable and have met all pt goals.Implanted- zimmer devices.There is no other information available.
Additional Manufacturer Narrative
H3.Investigation - the cc tibial insert with serial number (b)(6)is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's infection and revision surgery as related to the devices cannot be conclusively determined, however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.There is no mention of device malfunction or wear in the operative report.These devices are used for treatment not diagnosis.

• Brand Name: CC TIBIAL INSERT SZ 3, 18MM
• 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: michael crader
• MDR Report Key: 18901178
• Report Number: 1038671-2024-00497
• Device Sequence Number: 7887230
• Product Code: JWH
• UDI-Device Identifier: 10885862054289
• UDI-Public: 10885862054289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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: 04/07/2018
• Device Catalogue Number: 208-23-18
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2013
• 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: 80 YR
• Patient Sex: Male