MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FEMORAL HEAD 46MM; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 74123146

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported that the femoral head 46 mm collapsed.It was replaced with birmingham dual mobility and an anthology stem.There were no delays in the procedure.No other complications were reported.

Manufacturer Narrative

It was reported that revision surgery was performed due to the femoral head 46 mm that collapsed.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.As no device part and batch numbers were provided for investigation, a complaint history review, manufacturing record review and device labelling / ifu review could not be performed.All of the devices would have met manufacturing specifications.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.Reportedly the revision was due to collapse of the 46mm femoral head and it was replaced with a birmingham dual mobility with an anthology stem without delay.However, it was communicated that no further details and/or information were available.Based on the limited information provided, the root cause of the reported femoral head collapse and the patient impact beyond the reported revision could not be concluded.No further medical assessment is warranted at this time.Should clinically relevant documentation become available, the medical investigation task may be re-evaluated.Without return of the actual devices or further information we cannot further investigate the details supplied in this complaint.The investigation remains inconclusive and a definitive root cause cannot be determined.Due to insufficient information/based on the information provided we are unable to speculate/determine specific factors known to contribute to the alleged fault.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: FEMORAL HEAD 46MM
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10151755
• MDR Text Key: 195075173
• Report Number: 1020279-2020-02394
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 74123146
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/18/2020
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention