MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM XL/+12; PROSTHSIS, HIP, SEM-CONSTRND, METALCERAMPOLYM UN/CEMENTED R NO-POROUS

Catalog Number	71343612
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Swelling (2356)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery was performed due to infection, pain and swelling.The surgeon thinks it is not the product failure because it has taken long time after the primary surgery.The products was disposed so it cannot be returned.No more information is available.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: OXINIUM FEM HD 12/14 36 MM XL/+12
• Common Device Name: PROSTHSIS, HIP, SEM-CONSTRND, METALCERAMPOLYM UN/CEMENTED R NO-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7405820
• Report Number: 1020279-2018-00739
• Device Sequence Number: 19148427
• Product Code: LZO
• UDI-Device Identifier: 03596010520449
• UDI-Public: 03596010520449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2018

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: No Information
• Device Catalogue Number: 71343612
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/08/2018
• Supplement Report FDA Received Date: 06/03/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 70 YR