MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120156

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Bone Fracture(s) (1870); Failure of Implant (1924); Swelling (2091); Hip Fracture (2349); Osteolysis (2377)

Event Date 12/09/2015

Event Type  Death  

Event Description

It was reported that right hip revision surgery was performed.A subsequent revision was then performed (b)(6) 2016 at the same hospital; details of that procedure presently unknown.Patient died (b)(6) 2016.Pain, swelling, shortening, metal on metal wear debris, osteolysis, metallosis, failed right hip resurfacing, femoral neck periprosthetic fracture reported.Further details are being sought regarding the surgical procedures and the patient's death.

• Brand Name: BHR ACETABULAR CUP 56MM
• 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 5001 ; SZ 5001
• MDR Report Key: 7049019
• MDR Text Key: 92637798
• Report Number: 3005975929-2017-00401
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502599
• UDI-Public: 03596010502599
• 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: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 74120156
• Device Lot Number: 093906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 74121150, LOT # 087435
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 53 YR