MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD R3 40MM ID US COCR LNR 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 71341152

Device Problems Noise, Audible (3273); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Test Result (2695)

Event Date 11/04/2014

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to pain and popping.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

• Brand Name: R3 40MM ID US COCR LNR 52MM
• 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: 8835733
• MDR Text Key: 152465638
• Report Number: 3005975929-2019-00279
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 71341152
• Device Lot Number: 08MW20426
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2018
• Patient Sequence Number: 1
• Treatment: ACETABULAR SHELL, # 71331852, LOT # 08MM15838; HEMI HEAD, # 74122540, LOT # 08CW16074; HOLE COVER, # 71336500, LOT # 09CM16755; MODULAR SLEEVE, # 74222300, LOT # 08JW19038; ACETABULAR SHELL, # 71331852, LOT # 08MM15838; HEMI HEAD, # 74122540, LOT # 08CW16074; HOLE COVER, # 71336500, LOT # 09CM16755; MODULAR SLEEVE, # 74222300, LOT # 08JW19038
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR