MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD MODULAR HEAD 50 MM -4 (SHORT); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74121350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/27/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed on the patients right hip due to pain, elevated high ion metals on blood, evidence of adverse reaction to metal debris (armd).The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.The available medical documents were reviewed.No part/lot numbers were provided; hence documentation review could not be completed.If more information is received, this investigation will be reopened.Without the details of the devices involved in this complaint, a specific risk management review for the devices also cannot be performed.If this information becomes available at a later time, the task will be reopened and completed.Smith and nephew has not received the device/adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: MODULAR HEAD 50 MM -4 (SHORT)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10261810
• MDR Text Key: 198495324
• Report Number: 3005975929-2020-00240
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010503121
• UDI-Public: 3596010503121
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74121350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVE, SYNERGY; UNKN BHR MODULAR HEAD SLEEVE; UNKN SYNERGY HIP STEM
• Patient Outcome(s): Hospitalization; Required Intervention