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

Catalog Number 74122546

Device Problems Material Disintegration (1177); Patient Device Interaction Problem (4001)

Patient Problems Aspiration/Inhalation (1725); Pain (1994); Toxicity (2333); Test Result (2695)

Event Date 08/27/2018

Event Type  Injury  

Event Description

It was reported a revision surgery from the left hip was performed due to severe pain, elevated cobalt and chromium levels.

Manufacturer Narrative

In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.The available medical documents were reviewed.Patient has a history of falls, cocaine, opiate and marijuana use.The surgeon reported the patient¿s preoperative cobalt and chromium levels were chromium 16 and cobalt 61.3, however no lab report was provided.C-reactive protein was 78.6.An aspiration 15 months prior to revision yielded 620 ml of cloudy chocolate brown fluid, drained from left upper thigh.Cultures were negative for growth, but a lab report indicated synovial fluid polymorphonuclear cells as 54, lymph cells as 44 and mononuclear cells as 2.The intraoperative report indicated a large granuloma, filled with 300 ml of dark fluid with foreign body granuloma reaction within the walls of the pocket.It cannot be determined to what extent the patient¿s falls, cocaine, opiates and marijuana use had on his pain and clinical status.The intraoperative findings of a large granuloma filled with 300 ml of dark fluid, elevated white blood cell count, metal ions and c-reactive protein are all consistent with metallosis and infection.Without the support of imaging and the analysis of the explanted components the root cause of the clinical findings cannot be confirmed, and it cannot be concluded that the reported clinical findings were associated with mal-performance of the implant.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: 8130897
• MDR Text Key: 129293590
• Report Number: 3005975929-2018-00526
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Catalogue Number: 74122546
• Device Lot Number: 10539
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECHELON STEM UNKNOWN LOT AND PART NUMBER; FEMORAL HEAD UNKNOWN LOT AND PART NUMBER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR