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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to dislocation.No additional details of the revision surgery reported.Five explants reported.No delay or additional injuries reported.A back up device was available.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event is already reported on mdr 1020279-2019-01164, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8467981
• Report Number: 9613369-2019-00028
• Device Sequence Number: 1501312
• 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): 03/31/2019

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
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 03/31/2019
• 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: Other; Required Intervention