MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74120258

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Discomfort (2330)

Event Date 07/17/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.The patient reported some slight discomfort during his first check up.An x-ray was taken and acetabular loosening was seen.

Manufacturer Narrative

(b)(4).

• Brand Name: BHR DYSPLASIA CUP 58MM
• 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: 6731116
• MDR Text Key: 80620644
• Report Number: 3005975929-2017-00223
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010502681
• UDI-Public: 03596010502681
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2018

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: 06/30/2018
• Device Catalogue Number: 74120258
• Device Lot Number: 13DW09021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2013
• 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