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

Catalog Number 74120150

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Hearing Loss (1882); Pain (1994); Joint Disorder (2373); Confusion/ Disorientation (2553); Limited Mobility Of The Implanted Joint (2671)

Event Date 10/22/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to a soft tissue reaction.Implantation was in 2009.Pain, discomfort in hip, difficulty bearing weight, reduced mobility, tiredness, reduced concentration and dexterity reported.Exacerbation of arthritis, sinus problems and temporary hearing loss reported.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; spa park; harrison way; leamington spa ; UK
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; spa park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3772010
• MDR Text Key: 17617246
• Report Number: 3005477969-2014-00282
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: 74120150
• Device Lot Number: 76512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2014
• Date Device Manufactured: 07/09/2007
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR