MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 44MM ID US COCR LNR 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341156

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Failure of Implant (1924); Necrosis (1971)

Event Date 10/07/2009

Event Type  Injury  

Event Description

It was reported due to the patient chronic need of steroids he has developed avascular necrosis of the bilateral femoral head.Six (6) years post revision patient developed staphylococcus infection, which was then drained and iv antibiotics were given for two weeks.Revision surgery performed on both hips.

• Brand Name: R3 44MM ID US COCR LNR 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6180313
• MDR Text Key: 62543766
• Report Number: 3005975929-2016-00068
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

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
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 71341156
• Device Lot Number: 09AW20961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2017
• Date Device Manufactured: 03/10/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMI HEAD#74122544, LOT#08CW16094; MODULAR SLEEVE#74222400, LOT#07FW12490; R3 ACETABULAR SHELL#71335556, LOT#08LM06080; STEM#75002701, LOT#F0809074
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR