MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120160

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 09/06/2019

Event Type  Injury  

Event Description

The patient had been admitted to hospital for a knee revision but developed an infection.Whilst in hospital the patient start to dislocate his mom modular hip replacement.

• Brand Name: BHR ACETABULAR CUP 60MM
• 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: 8987607
• MDR Text Key: 157290336
• Report Number: 3005975929-2019-00319
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Catalogue Number: 74120160
• Device Lot Number: 51209
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71309012, LOT # UNKNOWN; MONOBLOCK HEAD, # 74121454, LOT UNKNOWN; FEMORAL STEM, # 71309012, LOT # UNKNOWN; MONOBLOCK HEAD, # 74121454, LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention