MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 46MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 12/05/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to pain, fluid collection and elevated cobalt and chromium levels.Co= 4.9 and cr= 5.4.Bhr head was removed.

Manufacturer Narrative

It was reported that 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/lot numbers a complete complaint history review cannot be performed for the devices involved.A review of the complaint history review was performed using the part number for a 46mm hemi head in search of complaints involving elevated test results throughout the lifetime of the product.Similar complaints have been identified and this failure will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review, ifu review and risk management review could not be performed.If more information is received, this investigation will be reopened.Without any supporting medical documentation, the reported event cannot be assessed, and a thorough medical assessment cannot be performed.In the event medical/clinical records are received, 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: HEMI HEAD 46MM
• 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: 9528745
• MDR Text Key: 173172553
• Report Number: 3005975929-2019-00460
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUP 74120152, LOT UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention