MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BIRMINGHAM HIP RESURFACING; RESURFACING FEMORAL HEAD 50MM

Catalog Number 74121150

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Test Result (2695)

Event Date 09/04/2018

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to increased symptoms and increasingly large cyst formation.

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: [212558 summary.Pdf].

• Brand Name: BIRMINGHAM HIP RESURFACING
• Type of Device: RESURFACING FEMORAL HEAD 50MM
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa, warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 7998921
• MDR Text Key: 124804901
• Report Number: 3005975929-2018-00387
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 74121150
• Device Lot Number: 78331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120156, LOT # 07GW12667; ACETABULAR CUP, # 74120156, LOT # UNKNOWN; ACETABULAR CUP, # 74120156, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR