MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71343608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that washout of hip and exchange xlpe liner and oxinium head due to infection.Primary hip replacement date: (b)(6) 2020.No report requested by surgeon.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that washout of hip and exchange xlpe liner and oxinium head due to infection.The affected oxinium femoral head, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported event could not be corroborated.The instructions for use noted the alleged failure has been identified in the potential adverse events.A review of risk management files found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to surgical technique used or patient medical conditions.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.

• Brand Name: OXINIUM FEM HD 12/14 36 MM L/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10258205
• Report Number: 1020279-2020-03044
• Device Sequence Number: 19457024
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 71343608
• Device Catalogue Number: 71343608
• Device Lot Number: 19FM22191
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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