MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Catalog Number 74122550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxicity (2333)

Event Date 12/21/2016

Event Type  Injury  

Event Description

It was reported that after a revision surgery performed on (b)(6) 2014 a new bhr femoral head and sleeve were implanted.On (b)(6) 2020 with the operative records it was confirmed that with the new implants on (b)(6) 2016 the patient was diagnosed with progressive elevated ion levels on blood (cobalt blood 10.9 mcg/l, chromium blood 2.7 mcg/l) no additional revision surgery has been scheduled so far.The patient outcome is unknown.

Manufacturer Narrative

It was reported that right hip revision surgery was performed.During the revision, the head and sleeve were removed.The 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.A review of the complaint history for the acetabular cup, hemi head and modular sleeve was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the hemi head and modular sleeve.Similar complaints have been identified for the acetabular cup and stem.This will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.The available medical documents were reviewed.Elevated metal ions were reported status post right hip revision with exchange of the smith and nephew femoral head.Metal ions levels (b)(6) 2018 were cobalt, blood 11.0 and chromium, blood 2.6.Mcg/l.It is noted on a (b)(6) 2018 physician¿s note that a decision would be made in (b)(6) 2019 regarding continued monitoring vs.Revision.To date no revision information has been provided.With the limited information provided, the root cause of the reported elevated metal ions cannot be confirmed and it cannot be concluded that the reported elevated ions were associated with a 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 50MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10624856
• MDR Text Key: 209759295
• Report Number: 3005975929-2020-00372
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556071205
• UDI-Public: 885556071205
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74122550
• Device Lot Number: 10KW13411
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SLEEVE 74222200/ LOT 10KW13411.; SLEEVE 74222200/LOT 10KW13411
• Patient Outcome(s): Other