MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 45MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number 126645

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

Patient Problem Joint Dislocation (2374)

Event Date 04/13/2020

Event Type  Injury  

Event Description

It was reported that, after a hip hemiarthroplasty, the patient suffered a dislocation.A revision surgery was performed to treat the event: the tandem unipolar head was explanted and replaced with a or3o implant.The patient outcome is unknown.

• Brand Name: TANDEM UNIPOLAR 45MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10026285
• MDR Text Key: 189914767
• Report Number: 1020279-2020-01467
• Device Sequence Number: 1
• Product Code: LZY
• UDI-Device Identifier: 03596010079749
• UDI-Public: 03596010079749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 126645
• Device Catalogue Number: 126645
• Device Lot Number: 19JM23005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention