MAUDE Adverse Event Report: ZIMMER GMBH NCB®, DF PLATE, LEFT, 13 HOLES, LENGTH 324 MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: report source italy.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient underwent revision due to breakage of plate on panel of pseudoarthrosis.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: NCB®, DF PLATE, LEFT, 13 HOLES, LENGTH 324 MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18968220
• MDR Text Key: 338484412
• Report Number: 0009613350-2024-00122
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024491939
• UDI-Public: (01)00889024491939(17)320317(10)3105075
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K192217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0202260113
• Device Lot Number: 3105075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR