MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD HEMI HEAD 48MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number 74122548

Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Metal Related Pathology (4530)

Event Date 04/23/2019

Event Type  Injury  

Event Description

It was reported that, after a left hip arthroplasty in which a bhr construct had been implanted, the patient experienced metallosis and immune tissue reaction.The patient underwent a medically-indicated revision of the bhr implants.The patient outcome is unknown.

Manufacturer Narrative

Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.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, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that, after a left hip arthroplasty in which a bhr construct had been implanted, the patient experienced metallosis and immune tissue reaction.The patient underwent a medically-indicated revision of the bhr implants.The patient outcome is unknown.

Manufacturer Narrative

It was reported that, after a left hip arthroplasty in which a bhr construct had been implanted, the patient experienced metallosis and immune tissue reaction.The patient underwent a medically-indicated revision of the bhr implants.The patient outcome is unknown.All of the implanted devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review, device labeling review and risk management could not be performed.If more information is received, this investigation will be reopened.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

It was reported that left 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 has not become available.A review of the complaint history for all devices was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaint have been identified for modular sleeve and hemi head.However, as the device is no longer sold, no action is to be taken.No other similar complaints were identified for r3 liner, r3 shell, stem and hole cover.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.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.The available medical documents were reviewed.The report pain, elevated metal ions, adverse local tissue reaction and osteolysis may be findings consistent with trunnionosis and metallosis; however the root cause of the pain, elevated metal ions, adverse local tissue reaction and osteolysis cannot be confirmed and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined; however, 6wks post revision it was noted patient was doing very well.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 48MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire, ; UK
• MDR Report Key: 10103805
• MDR Text Key: 193011208
• Report Number: 3005975929-2020-00168
• Device Sequence Number: 1
• Product Code: KWL
• 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,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2013
• Device Catalogue Number: 74122548
• Device Lot Number: 08MW20383
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention