MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 74120154

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Test Result (2695)

Event Date 05/04/2019

Event Type  Injury  

Event Description

It was reported that a bilateral patient (this side right) presented metallosis.Patient was revised for left side and reported via mdr 3005975929-2020-00122.

• Brand Name: BHR ACETABULAR CUP 54MM
• 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: 10513092
• MDR Text Key: 206276317
• Report Number: 3005975929-2020-00333
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502582
• UDI-Public: 03596010502582
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2014
• Device Model Number: 74120154
• Device Catalogue Number: 74120154
• Device Lot Number: 09BW22068
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Patient Sequence Number: 1
• Treatment: FEMORAL STEM, # 71306613, LOT # 09JM13147.; HEMI HEAD, # 74122548, LOT # 08FW17374.; MODULAR SLEEVE, # 74222100, LOT # 08AW15249.; FEMORAL STEM, # 71306613, LOT # 09JM13147; HEMI HEAD, # 74122548, LOT # 08FW17374; MODULAR SLEEVE, # 74222100, LOT # 08AW15249
• Patient Weight: 79