MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR RESURFACING FEMORAL HEAD 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74123152

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Necrosis (1971); Hip Fracture (2349)

Event Date 08/07/2019

Event Type  Injury  

Event Description

Revision surgery was performed due to necrosis of the femoral head.

Event Description

On (b)(6) 2019 surgeon confirmed that patient "fell and suffered a periprosthetic pertrochanteric fracture.Since the cup was firmly fixed, the custom made device was ordered so that the cup had not be removed.It was a purely trauma event without involvement of the prosthesis system.¿.

Manufacturer Narrative

Part details corrected in other #.52mm head, not 42 as previously reported.Cup details in concomitant medical products corrected.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 RESURFACING FEMORAL HEAD 52MM
• 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: 8909522
• MDR Text Key: 154840572
• Report Number: 3005975929-2019-00294
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502773
• UDI-Public: 03596010502773
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74123152
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, # 74120158, LOT # UNKNOWN; ACETABULAR CUP, # 74122158, LOT # UNKNOWN; ACETABULAR CUP, # 74120158, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR