MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB SCR I4.0 SELF-TAPPING 26MM; NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to periprosthetic fracture.Contributing factors: surgeon reports poor bone stock in the revision operation so i think it is safe to assume she had osteoporosis.There were no signs of infection noted.No signs of callus noted so would be classed as a delayed union given it was only 5-6 weeks after the first operation i think its too early to call it a non-union.
Additional Manufacturer Narrative
Additional information was received.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 or Problem Description
See h10.

• Brand Name: NCB SCR I4.0 SELF-TAPPING 26MM
• Common Device Name: 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: 11192036
• Report Number: 0009613350-2021-00025
• Device Sequence Number: 3940941
• Product Code: HRS
• UDI-Device Identifier: 00889024291409
• UDI-Public: 00889024291409
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 02.02155.026
• Device Lot Number: 2841143
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 79