MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 60MM; ACETABLR CUP

Catalog Number 74120160

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 09/15/2014

Event Type  Injury  

Event Description

A luxation of a hip has been reported.The hip was relocated under general anaesthetic.

Manufacturer Narrative

The devices will not be evaluated because they are still in situ.

Event Description

Revision has been performed due to repeated (3x) dislocations in (b)(6) 2014, (b)(6) 2015.Patient reports being hospitalized for about 1 month post revision due to problems with metallosis and infection.Patient also reported dislocations and subsequent problems with metallosis, along with getting bandage changes as one part of the wound is stubborn to heal due to a suspected "pseudo-tumour" and infection at the distal end of the wound.

• Brand Name: BHR ACETABULAR CUP 60MM
• Type of Device: ACETABLR CUP
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; baar; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 4249445
• MDR Text Key: 18091785
• Report Number: 3005477969-2014-00561
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P04003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: 74120160
• Device Lot Number: 51005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2016
• Date Device Manufactured: 03/03/2005
• 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
• Patient Age: 57 YR