MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD; PRSTHSS,HIP,SMICNSTRAIND,METAL/POLYMER,CMNTD

Catalog Number	71343603
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation.
Additional Manufacturer Narrative
Please review attached for the investigation results.

• Brand Name: OXINIUM FEM HD
• Common Device Name: PRSTHSS,HIP,SMICNSTRAIND,METAL/POLYMER,CMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6930188
• Report Number: 1020279-2017-00841
• Device Sequence Number: 16531426
• Product Code: JDI
• UDI-Device Identifier: 00885556020227
• UDI-Public: 00885556020227
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2018

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: 71343603
• Device Lot Number: 17CM11911
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 09/15/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 10/19/2017; 03/07/2018
• 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: 71 YR