MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 130D; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	71675386
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to correct an intertan nail breakage due to stress and fatigue.

• Brand Name: INTERTAN 10S 10MM X 20CM 130D
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9902829
• Report Number: 1020279-2020-01095
• Device Sequence Number: 19512505
• Product Code: JDG
• UDI-Device Identifier: 00885556343692
• UDI-Public: 00885556343692
• Combination Product (Y/N): N
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71675386
• Device Catalogue Number: 71675386
• Device Lot Number: 17AM01326
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention