MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM HD 10/12 32MM +0 EXT; PROSTHESIS,HIP,SEMICONSTRAIND,METL/CERAMIC/POLYMR,CMNTD ORNONPOROUS,UNCMNTD

Catalog Number	71341940
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to infection.The product was disposed.
Additional Manufacturer Narrative
Investigation results : the associated complaint devices were not returned.The clinical/medical team concluded, it was reported that a revision surgery was performed due to infection approximately 2 years post implantation.It was communicated that the surgeon does not fault the device, as the infection occurred so long after the initial implantation.The explants will not be returned for evaluation, as it was reported that they were disposed of.Additionally, there are no radiographs or patient medical records to be provided for review.Therefore due to insufficient information, a clinical assessment cannot be performed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches/failure mode.Product was sterilized according to sterilization release documentation from quality control.

• Brand Name: OXINIUM HD 10/12 32MM +0 EXT
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAIND,METL/CERAMIC/POLYMR,CMNTD ORNONPOROUS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7180674
• Report Number: 1020279-2018-00043
• Device Sequence Number: 877630
• Product Code: LZO
• UDI-Device Identifier: 00885556112441
• UDI-Public: 00885556112441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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 Expiration Date: 05/15/2026
• Device Catalogue Number: 71341940
• Device Lot Number: 16EM12984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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