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

Catalog Number 74121154

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Loss of Range of Motion (2032); Toxicity (2333); Test Result (2695)

Event Date 08/06/2015

Event Type  Injury  

Event Description

It was reported that patient underwent right hip revision surgery due to limited motion and elevated cobalt and chromium ions refractory to revision of contralateral metal-on-metal resurfacing system.

• 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: markus poettker ; schachenallee 29; aarau 05001 ; SZ 05001
• MDR Report Key: 7154031
• MDR Text Key: 96025918
• Report Number: 3005975929-2017-00473
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502612
• UDI-Public: 03596010502612
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 74121154
• Device Lot Number: 087223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2017
• Date Device Manufactured: 04/23/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESURFACING FEMORAL HEAD 54MM, 74121154/087223
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR