MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR MODULAR HEAD 42MM -4 (SHORT); PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,

Catalog Number 74121342

Device Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 02/22/2017

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.The acetabular cup was well fixed.The femoral component appeared well fixed, however there was a small defect in the superior part of the femoral neck, which the surgeon thought could represent a subchondral fracture.There seemed to be slight discolouration in the tissues in the hip joint.

• Brand Name: BHR MODULAR HEAD 42MM -4 (SHORT)
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL,
• 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; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia desantis ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6383306
• MDR Text Key: 69204965
• Report Number: 3005975929-2017-00051
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2009
• Device Catalogue Number: 74121342
• Device Lot Number: 33476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2004
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACETABULAR CUP, PART AND LOT # UNKNOWN; FEMORAL STEM, PART AND LOT # UNKNOWN; MODULAR SLEEVE, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR