MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB SCR 4.0 SELF TAPPING 26MM; NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

Model Number N/A

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/16/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on an unknown side and underwent revision surgery due to periprosthetic fracture.

Manufacturer Narrative

Additional information was received.Additional: h2.Correction: b4, g4, g7, h10.This device was moved from main product to associated product as the main product (ncb shaft plate, reported with mdr report number 0009613350-2020-00599) fractured.Please invalidate this case from your system.Zimmer gmbh will invalidate this case from the system.Zimmer reference number of this file is (b)(4).

Event Description

See h10.

• Brand Name: NCB SCR 4.0 SELF TAPPING 26MM
• Type of Device: NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11192031
• MDR Text Key: 227495200
• Report Number: 0009613350-2021-00019
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00889024291409
• UDI-Public: 00889024291409
• Combination Product (y/n): N
• PMA/PMN Number: K061211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 02.02155.026
• Device Lot Number: 2824669
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 79