MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN POR PLUS HA HO STEM SZ 13; PRSTHSS,HP,SMCNSTRND,UNCMNTD,MTLPLYMRNNPRS,CLCMPSPT

Catalog Number	71309113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to periprosthetic fracture.

• Brand Name: SYN POR PLUS HA HO STEM SZ 13
• Common Device Name: PRSTHSS,HP,SMCNSTRND,UNCMNTD,MTLPLYMRNNPRS,CLCMPSPT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7500948
• Report Number: 1020279-2018-00904
• Device Sequence Number: 16573520
• Product Code: MEH
• UDI-Device Identifier: 03596010459787
• UDI-Public: 03596010459787
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002996
• 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): 05/09/2018

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: 71309113
• Device Lot Number: 17DM13890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/09/2018
• 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