MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRL 32MM LAT +4 50-52MM SZ E; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number 71363253

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/02/2018

Event Type  Injury  

Event Description

It was reported that during surgery, when the doctor utilized the liner trial after the reflection cup had been inserted, the thread of the liner trial was dropped off.The device broke inside of the patient but it was retrieved from the wound.

Manufacturer Narrative

The trial liner assembly was returned and evaluated.A visual inspection found that the material around the proximal section of the through hole has failed.This failure released the screw and has created three separate pieces; all three pieces were returned.We recommend that all reusable instruments be routinely inspected for wear and damage so they may be replaced as necessary.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.A complaint history review revealed no additional complaints.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TRL 32MM LAT +4 50-52MM SZ E
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8020607
• MDR Text Key: 125519470
• Report Number: 1020279-2018-02315
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010512369
• UDI-Public: 03596010512369
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71363253
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1