MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 3 NON-CEM; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100476
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	02/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to peri prosthetic fracture.The patient fractured the femur around the stem after falling off a bike.During the procedure, the stem and the femoral head were replaced and accord cables were placed around femur shaft to fix the fracture.Primary surgery was a thr performed on (b)(6) 2014.
Additional Manufacturer Narrative
Investigation results: it was reported that a revision surgery was performed due to periprosthetic fracture.The patient fractured the femur around the stem after falling off a bike.During the procedure, the stem and the femoral head were replaced and accord cables were placed around femur shaft to fix the fracture.Primary surgery was a total hip replacement performed on (b)(6) 2014.The claimed stem was a polarstem stem lat.Ti/ha 3 non-cem, which intent use is in treatment.The device was not returned for investigation.Furthermore, no x-rays were provided to fully confirm the reported fracture.A product history review was performed, but no deviation could be found in the corresponding batch record.No other complaint can be found for the corresponding batch number.One similar complaint, which reports a periprosthetic fracture, was recorded for the specific article number.The risk of a periprosthetic fracture is covered in our specific risk file and corresponding instruction for use for hip implants [lit.12.23, ed.05/16].After the performed investigation the reported fall is stated as original cause for the fracture.No device problem was found and no further actions are planned.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM LAT.TI/HA 3 NON-CEM
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11409072
• Report Number: 9613369-2021-00093
• Device Sequence Number: 17107062
• Product Code: LZO
• UDI-Device Identifier: 07611996118674
• UDI-Public: 07611996118674
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Expiration Date: 06/25/2020
• Device Model Number: 75100476
• Device Catalogue Number: 75100476
• Device Lot Number: A1307984
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/06/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/15/2021
• 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