MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 22 MM +4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	OR71342204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed on the patient due to a dislocation.No additional information specified.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re assessed.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 22 MM +4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8299088
• Report Number: 1020279-2019-00388
• Device Sequence Number: 1911528
• Product Code: LZO
• UDI-Device Identifier: 03596010488879
• UDI-Public: 03596010488879
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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 Catalogue Number: OR71342204
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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