MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD UNKN BIRMINGHAM HIP RESURFACING CUP; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problems Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348)

Event Date 03/15/2019

Event Type  Injury  

Event Description

It was reported left hip revision surgery due to hip pain, elevated cobalt and chromium levels, and a ct scan revealed apparent loosening around the femoral component keel, with no cortical irregularity.

Manufacturer Narrative

It was reported that the right hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.Without definitive part and lot numbers a complaint history and dhr review cannot be performed for the devices involved.Should the lot/batch/serial number become available at a later date then the complaint history and dhr task will be re-opened and completed.A risk management review was performed.No additional risks were identified as result of the reported event.No further actions are required at this time.No medical records or evidence have been received on this complaint.The reported event cannot be assessed and a thorough medical assessment cannot be performed.If notification is received that additional medical documentation has been provided, this complaint will be re-evaluated and a thorough medical assessment rendered.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.

• Brand Name: UNKN BIRMINGHAM HIP RESURFACING CUP
• 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: 9384045
• MDR Text Key: 168242443
• Report Number: 3005975929-2019-00414
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN BIRMINGHAM HIP RESURFACING HEAD
• Patient Outcome(s): Hospitalization; Required Intervention