MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM -3; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71330001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.All the components were removed.

• Brand Name: OXINIUM FEM HD 12/14 32MM -3
• 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: 9349938
• Report Number: 1020279-2019-04101
• Device Sequence Number: 11648060
• Product Code: LZO
• UDI-Device Identifier: 03596010196590
• UDI-Public: 03596010196590
• 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 Implanted Year: 2006
• Device Explanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 71330001
• Device Catalogue Number: 71343203
• Device Lot Number: 05HM10078
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 10/01/2021
• 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
• Patient Age: 52 YR