MAUDE Adverse Event Report: ZIMMER TMT NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ TIBIAL FULL BLOCK AUGMENT; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during an initial tka, the intended device for use did not have a screw hole, as expected, to attach to the stemmed tibia.There were concerns that the device was incorrectly packaged and labeled.The device was implanted into the patient and not removed.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were update/corrected updated: b4, b5, g4, g7, h2, h3, h6 no product or pictures were provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A review of the device plans determined that no failure was found as the product does not contain screw holes.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NEXGEN® COMPLETE KNEE SOLUTION, TRABECULAR METAL¿¢ TIBIAL FULL BLOCK AUGMENT
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• MDR Report Key: 9409414
• Report Number: 3005751028-2019-00043
• Device Sequence Number: 14503799
• Product Code: JWH
• UDI-Device Identifier: 00889024308060
• UDI-Public: (01)00889024308060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K024161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00544800610
• Device Lot Number: 64131045
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1