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

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 06/03/2020

Event Type  Injury  

Event Description

It was reported that the stem impactor rod fractured at the tip during surgery.The procedure was to remove a smith and nephew anthology stem due to an infection.The tip of the inserter was left inside the prosthesis and nothing was left inside the patient.Procedure was finished with a backup instrument.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, per complaint details, the stem revision was due to an infection.However, s+n has not received adequate patient specific information/documentation to fully evaluate the root cause of the reported event.The patient impact beyond the reported infection and subsequent revision could not be determined as no medical documentation or responses to medical documentation requests have been provided as of the date of this investigation.No further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ANTHOLOGY HIP IMPL
• 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: 10607848
• MDR Text Key: 209212713
• Report Number: 1020279-2020-04975
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention