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

Catalog Number 74121154

Device Problem Malposition of Device (2616)

Patient Problems Toxicity (2333); No Code Available (3191)

Event Date 09/01/2009

Event Type  Injury  

Event Description

It was reported there was a malposition of a bhr left hip femoral component, revision of the left hip was performed to a total hip arthroplasty.The customer then went on to experience high metal ion levels and had revision of total left hip.

• Brand Name: RESURFACING FEMORAL HEAD 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5980134
• MDR Text Key: 55721331
• Report Number: 3005975929-2016-00016
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 74121154
• Device Lot Number: 086713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP 74120160, LOT 08813; HEMI HEAD 74122554, LOT 07JW13585; SLEEVE 74222200, LOT 08HW18188; STEM 71306611, LOT 08DM20071A
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR