MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; HIP-DUMMY IMPLANT

Catalog Number 74120150

Device Problem Insufficient Information (3190)

Patient Problems Tissue Damage (2104); Malaise (2359); Limited Mobility Of The Implanted Joint (2671); Fluid Discharge (2686); Test Result (2695)

Event Date 11/09/2015

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.In (b)(6), the patient lost power in hip and felt unwell.Blood samples taken.Mri reportedly showed fluid and deterioration.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR ACETABULAR CUP 50MM
• Type of Device: HIP-DUMMY IMPLANT
• 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
• MDR Report Key: 5343700
• MDR Text Key: 35056829
• Report Number: 3005477969-2016-00003
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Catalogue Number: 74120150
• Device Lot Number: 58850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2006
• 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
• Patient Outcome(s): Hospitalization; Required Intervention