MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF SPHER HEAD SCREW 20MM; PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CA-PHOSPHATE

Catalog Number	71332520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had first stage revision hip arthroplasty due to infected thr on (b)(6) 2018 by dr.(b)(6).Primary procedure was done at (b)(6) by dr.(b)(6) on (b)(6) 2018.

• Brand Name: REF SPHER HEAD SCREW 20MM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAINED,UNCEMENTED,METAL/POLYMER,NON-POROUS,CA-PHOSPHATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7489566
• Report Number: 1020279-2018-00878
• Device Sequence Number: 145102
• Product Code: MEH
• UDI-Device Identifier: 03596010460455
• UDI-Public: 03596010460455
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2018

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: 71332520
• Device Lot Number: 17HB00411
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/06/2018
• 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