MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122158

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Swelling (2091); Toxicity (2333); Arthralgia (2355); Test Result (2695)

Event Date 04/27/2015

Event Type  Injury  

Event Description

Patient reported right hip pain.Elevated metal ion levels, and mri showed a collection of fluid with no eveidence of pseudotumor.Revision surgery performed.

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.

• Brand Name: BHR ACETABULAR CUP 58MM
• 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: 5874951
• MDR Text Key: 52058291
• Report Number: 3005477969-2016-00204
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Catalogue Number: 74122158
• Device Lot Number: 08KW19732
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMI HEAD 52MM, 74122552. LOT#08LW20010; MODULAR SLEEVE, 74222200. LOT#08CW16023; STEM, 75002759. LOT#0604133026; STEM, 75002759. LOT#0604133026
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR