MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71356107

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 04/22/2013

Event Type  Injury  

Event Description

It was reported that right hip revision surgery was performed due to mechanical loosening and fibrous fixation of the stem.

• Brand Name: ANTHOLOGY HIGH OFFSET FEMORAL STEM SIZE 7
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9382709
• MDR Text Key: 168193882
• Report Number: 1020279-2019-04173
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010567895
• UDI-Public: 03596010567895
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Model Number: 71356107
• Device Catalogue Number: 71356107
• Device Lot Number: 11FM17364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Patient Sequence Number: 1
• Treatment: FEMORAL HEAD, # 71343504, LOT # 11AM15190; FEMORAL HEAD, # 71343504, LOT # 11AM15190
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR