MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN ORTHOPAEDIC RECONSTRUCTION DEV; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number UNKN01000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 11/14/2008

Event Type  Injury  

Event Description

It was reported that after the patient was treated with a total left hip in (b)(6) 2008, she started complaining of recurrent nausea and an unpleasant feeling of heart stumbling and rapid heartbeat.She was hospitalized and medicated from (b)(6) 2008.

Manufacturer Narrative

Results of investigation: it was reported that after the patient was treated with a total left hip in (b)(6) 2008, she started complaining of recurrent nausea and an unpleasant feeling of heart stumbling and rapid heartbeat.The device intended for use in treatment was not returned for investigation nor was a batch number communicated.An appropriate investigation could therefore not be conducted and the reported failure mode could not independently be confirmed.A medical investigation was conducted based on available medical records.The reported recurrent nausea, heart stumbling and rapid heartbeat are related to the urosepsis and/or the valvular and hypertensive heart disease and is not associated with a mal-performance of the implant.The patient was treated with medication and was being followed by cardiology.Ifu (lit.No.12.23 ed 05/16) lists several adverse issues as a known possible side effect resulting from a hip arthroplasty.A review of the risk management documentation verifies the failure mode and severity of the reported issue.Based on the information provided, the root cause for the reported issue is not related to the device.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: UNKN ORTHOPAEDIC RECONSTRUCTION DEV
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11409093
• MDR Text Key: 234625844
• Report Number: 9613369-2021-00095
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKN01000000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention