MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HO TR NECK SZ 7-12; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71365807

Device Problems Material Disintegration (1177); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

It was reported during the procedure, thr, that the coating on trial necks wear off, causing that the magnet detaches from the trial neck.The procedure was completed without delay, using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device's coating is wearing off the magnetic mechanism part of device, rendering device inoperable.The device shows signs of extensive use.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY HO TR NECK SZ 7-12
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10655506
• MDR Text Key: 210605827
• Report Number: 1020279-2020-05291
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010559883
• UDI-Public: 03596010559883
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71365807
• Device Catalogue Number: 71365807
• Device Lot Number: 14CM040484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 07/21/2021
• Supplement Dates FDA Received: 11/18/2020; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1