MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP HAP SIZE 52/58; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 08/12/2015

Event Type  Injury  

Event Description

Pain *us legal claim* it was reported revision surgery occurred due to hip pain and other complications.(not specified).

Manufacturer Narrative

[(b)(4)].

Manufacturer Narrative

Date of event & other corrected following receipt of operative reports.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.- attachment: [130389 summary.Pdf].

• Brand Name: BHR ACETABULAR CUP HAP SIZE 52/58
• 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: 6185038
• MDR Text Key: 62699502
• Report Number: 3005975929-2016-00070
• 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,Followup,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 74122158
• Device Lot Number: 10LW30828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2016
• Patient Sequence Number: 1
• Treatment: RESURFACING FEMORAL HEAD 52MM PART & LOT UNKNOWN; RESURFACING FEMORAL HEAD 52MM PART & LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR