MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 38MM ID INTL COCR LINER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71335850

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Toxicity (2333)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported patient asymptomatic but with elevated serum chromium and cobalt levels.Acetabular liner, modular head and sleeve removed at revision surgery.Femoral stem loose so revised with different product.

Manufacturer Narrative

Upon receipt of further information, it has been determined that this reports represents a duplicate of mdr 3005975929-2017-00080.Please see that report for our evaluation of this case and disregard this report.

• Brand Name: R3 38MM ID INTL COCR LINER 50MM
• 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
• MDR Report Key: 5989851
• MDR Text Key: 56003635
• Report Number: 3005975929-2016-00020
• 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: consumer,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 71335850
• Device Lot Number: 08GW17892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BHR MODULAR HEAD # LOT 08AW15361.; MODULAR SLEEVE 74222300, LOT#08JW19036.; BHR MODULAR HEAD # LOT 08AW15361; MODULAR SLEEVE 74222300, LOT#08JW19036