MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLARSTEM CEMENTLESS STEM STD TI.HA 4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	75100467
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a hip revision surgery was performed due to peri-prosthetic fracture.
Additional Manufacturer Narrative
Additional mfr narrative: describe event or problem, other relevant history.Mfr name, city, and state, mfr site.This event will be closed as it was identified as duplicate of event reported under 9613369-2019-00023.
Event or Problem Description
It was reported that a hip revision surgery was performed due to peri-prosthetic fracture.Stem was identified as broken.

• Brand Name: POLARSTEM CEMENTLESS STEM STD TI.HA 4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• MDR Report Key: 8430111
• Report Number: 1020279-2019-01086
• Device Sequence Number: 199087
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K130728
• 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): 05/28/2019

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: 75100467
• Device Lot Number: A1415520
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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