MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXNM FEM HD 28MM +16; PROSTHSISHIPSEMICONSTRAINDMTALCERAMICPOLYMERCMNTORNONPOROUSUNCMNTD

Model Number	71342816
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.Nothing wrong with implant.

• Brand Name: OXNM FEM HD 28MM +16
• Common Device Name: PROSTHSISHIPSEMICONSTRAINDMTALCERAMICPOLYMERCMNTORNONPOROUSUNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9711119
• Report Number: 1020279-2020-00543
• Device Sequence Number: 2500372
• Product Code: LZO
• UDI-Device Identifier: 03596010474193
• UDI-Public: 03596010474193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71342816
• Device Catalogue Number: 71342816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention