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

Catalog Number 74122546

Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problems Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 03/21/2019

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated ion levels, synovium stained with metal debris.

Manufacturer Narrative

It was reported that left hip revision surgery was performed.During the revision, the hemi head and sleeve were removed.The bhr cup and stem remained implanted.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 lot numbers a complete complaint history review cannot be performed for the bhr cup, hemi head and sleeve involved.A review of the complaint history review was performed using the part number for a bhr cup, hemi head and modular sleeve in search of complaints involving ¿debris¿ throughout the lifetime of the product.Similar complaints have been identified for the hemi head, bhr cup and modular sleeve.This failure will continue to be monitored.As no device batch numbers were provided for investigation, a manufacturing record review and ifu review could not be performed.If more information is received, this investigation will be reopened.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The reported pain and elevated metal ions along with intraoperative findings of metal tinged synovial fluid with a synovium stained with metal debris may be consistent with findings associated with metal debris and synovitis.However, the root cause of the metal staining and synovitis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a malperformance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.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.

Manufacturer Narrative

Part details in d1, d4, d11 and b6 test results updated.

• 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: 9659588
• MDR Text Key: 177403077
• Report Number: 3005975929-2020-00034
• 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,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 74122546
• Date Manufacturer Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODULAR SLEEVE, PART AND LOT # UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR