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

Catalog Number 74122154

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Date 10/02/2014

Event Type  Injury  

Event Description

It was reported that revision surgery was performed due to aseptic loosening.A 3/12 hx of pain reported.

• Brand Name: BHR
• Type of Device: ACETABULAR CUP
• 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, spar park; harrison way; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716 ; 4419264823
• MDR Report Key: 4168166
• MDR Text Key: 19301953
• Report Number: 3005477969-2014-00531
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 74122154
• Device Lot Number: 09MW25227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2010
• 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: DISTAL CENTRALIZER, # 71313104, LOT # 09FM20420; FEMORAL STEM, # 71312103, LOT # 09LT36783; MODULAR HEAD, # 74222148, LOT # 08LW19917
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 60