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

Catalog Number 74120160

Device Problems Collapse (1099); Metal Shedding Debris (1804)

Patient Problem Osteolysis (2377)

Event Date 01/04/2017

Event Type  Injury  

Event Description

It was reported that the femoral neck had collapsed.Revision surgery perfomed, it was noted during surgery there was a small amounts of metal debris around the cup.Osteolysis of the pubis was noted.Also noted as copmlications at revision were thin acetabulum & posterior wall deficiencies.There was minimal ingrowth into the acetabular cup noted at the time of revision.

• Brand Name: BHR
• 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 de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6253604
• MDR Text Key: 64917443
• Report Number: 3005975929-2017-00019
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2009
• Device Catalogue Number: 74120160
• Device Lot Number: 50319
• Other Device ID Number: 044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2004
• 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: FEMORAL HEAD# PART AND LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR