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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8020607
• Report Number: 1020279-2018-02315
• Device Sequence Number: 1640741
• Product Code: JDH
• UDI-Device Identifier: 03596010512369
• UDI-Public: 03596010512369
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71363253
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1