MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +0; PROSTH, HIP, SEMI-CON, METAL/CERAM/POLY, CEM OR NON-PORO, UNCEM

Model Number 71342800

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

Patient Problem Injury (2348)

Event Date 11/30/2017

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to trunnion corrosion and pain on the left hip on (b)(6) 2017.

• Brand Name: OXINIUM FEM HD 12/14 28MM +0
• Type of Device: PROSTH, HIP, SEMI-CON, METAL/CERAM/POLY, CEM OR NON-PORO, UNCEM
• 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: 10022353
• MDR Text Key: 189781518
• Report Number: 1020279-2020-01439
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474148
• UDI-Public: 03596010474148
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2019
• Device Model Number: 71342800
• Device Catalogue Number: 71342800
• Device Lot Number: 09CM0344
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2009
• 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
• Patient Age: 71 YR