MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR; ACETABULAR CUP

Catalog Number 74120160

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Pain (1994); Toxicity (2333); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 05/29/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.From (b)(6) 2012 pain, fatigue, reduced walking distance and reduced range of motion reported.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 4127426
• MDR Text Key: 4943945
• Report Number: 3005477969-2014-00511
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 74120160
• Device Lot Number: 10CW26312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Date Device Manufactured: 04/20/2010
• 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, # 74122554, LOT # 08LW19933; MODULAR SLEEVE, # 74222100, LOT # 10CW25951; FEMORAL STEM, # 71309017, LOT # 10DM14120
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR