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

Catalog Number 74122546

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Test Result (2695)

Event Date 07/21/2015

Event Type  Injury  

Event Description

It was reported that left hip revision surgery was performed due to elevated metalo ion levels.Implanted (b)(6) 2009.

Manufacturer Narrative

It was reported that left hip revision surgery was performed due to elevated metal ion levels.During revision the hemi head and the modular sleeve were removed.The bhr cup and synergy stem remained implanted.As of today, device return and additional information has been requested for this complaint but has not become available.In the absence of the actual devices, the production records were reviewed for the known 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.According to the provided revision report, the patient started having pain recently before the revision and had increased blood metal ions.The cup and stem were well fixed and the cup showed no wear spots and left in-vivo.Review of the provided surgical report did not indicate any inconsistencies with the surgical technique or other factors that could explain the reported findings.No additional information on the blood metal ions was provided.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

Smith + nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith + nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith + nephew, or its employees, that the report constitutes an admission that the device, smith + nephew or its employees caused or contributed to the potential event described in this report.- attachment: [184595 summary.Pdf].

• 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: 7352051
• MDR Text Key: 102907743
• Report Number: 3005975929-2018-00105
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2013
• Device Catalogue Number: 74122546
• Device Lot Number: 08EW17163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETLR CUP 74120152 LOT 087173; FEM COMP 71306614 LOT 09AM18792; FEMORAL HEAD, PART AND LOT # UNKNOWN; MODLR SLEEVE 74222200 LOT 08CW16017; FEMORAL HEAD, PART AND LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR