MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; BHR ACETABULAR CUP 54MM

Catalog Number 74122154

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374); Reaction (2414)

Event Date 07/08/2018

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to dislocation and a alval reaction.

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.- attachment: [208051 summary.Pdf].

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: BHR ACETABULAR CUP 54MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7800543
• MDR Text Key: 117697737
• Report Number: 3005975929-2018-00285
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010552297
• UDI-Public: 03596010552297
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122154
• Device Lot Number: 09GW24405 012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Date Manufacturer Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71356109, LOT # UNKNOWN; MODULAR HEAD, # 74222148, LOT # 09DW23058; MODULAR HEAD, # 74222150, LOT # UNKNOWN; MODULAR SLEEVE, # 74222100, LOT # OBSCURED; MODULAR SLEEVE, PART AND LOT # UNKNOWN; MODULAR HEAD, # 74222150, LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention