MAUDE Adverse Event Report: SMITH & NEPHEW BHR ACETABULAR CUP 48MM

Catalog Number 74120148

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Failure of Implant (1924); Muscle Weakness (1967); Pain (1994); Toxicity (2333); Ambulation Difficulties (2544)

Event Date 02/01/2013

Event Type  Injury  

Event Description

It was reported that revision surgery was performed.Pain, weakness of the legs and hips, elevated cobalt and chromium levels, fluid accumulations around the hip, difficulty ambulating and squeaking noises emanating from his hip reported.

Event Description

Lawsuit forms from patient's lawyer indicates the following, "the injuries, conditions, and complications suffered due to defendant's metal-on-metal hip implant products include, but are not limited to, excruciating pain, weakness of the legs and hips, elevated cobalt-chromium levels, fluid accumulations around the hip, and revision surgery" and "defendant's metal-on-metal hip implant products were used in plaintiff's surgery at (b)(6) hospital in (b)(6), new york on or about on (b)(6) 2011 where plaintiff's surgeon implanted a smith & nephew birmingham hip resurfacing system in place to plaintiff's right hip joint.Following the surgery, plaintiff' suffered from severe pain and discomfort, difficulty ambulating, squeaking noises emanating from his hip, fluid collection at his hip joint, and elevated metal ion levels in his blood.On (b)(6) 2013, plaintiff underwent a painful, complex and risky surgery (known as a "revision surgery") to remove and replace the smith & nephew bhr device that had failed prematurely.Revision surgeries are generally more complex than the original hip replacement surgery, often because there is a reduced amount of bone in which to place the new hip implants.Revision surgeries also usually take longer than the original hip replacement surgery and the revision surgery has a higher rate of complications." 03/09/2017, updated paperwork, including part sizes and surgeons, received.

• Brand Name: BHR ACETABULAR CUP 48MM
• Type of Device: ACETABULAR CUP
• Manufacturer (Section D): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW; 1 kingmaker court; warwick technology park; warwick CV34 6WG; UK CV34 6WG
• Manufacturer Contact: michael simmonds ; 4419264823
• MDR Report Key: 3603177
• MDR Text Key: 4069039
• Report Number: 3005477969-2014-00110
• Device Sequence Number: 1
• Product Code: NXT
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 74120148
• Device Lot Number: 11AW31488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: No
• 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: FEMORAL HEAD, # 74123148, LOT # 11BW31710.; FEMORAL HEAD, PART & LOT # UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male