MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY STD BROACH SIZE 7; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71365607

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 01/22/2020

Event Type  Injury  

Event Description

It was reported that during a thr procedure, the size 7 broach went deeper down the femur than the size 6.No sign of fracture.The surgeon thinks the broach may be defective.No delays reported.A backup device was available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include improper device size used or a procedural error.

• Brand Name: ANTHOLOGY STD BROACH SIZE 7
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9728785
• MDR Text Key: 181625522
• Report Number: 1020279-2020-00636
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010560025
• UDI-Public: 03596010560025
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71365607
• Device Catalogue Number: 71365607
• Device Lot Number: 16AM11846
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1