MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 2 NON-CEM; PROSTHESIS,HIP,SEMI-CONSTRAIN, METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT

Catalog Number	75100475
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after removing 2 broach, surgeon noted a longitudinal fracture approximately 3cm down the length of femur and then turned posteriorly.Event marked as serious.Intraoperative periprosthetic fracture of right femur.No broach details are known at this point.Please note that on (b)(6) 2018 aemb considered this event to be related to the surgical technique of femoral stem and thus to the polarstem device, which is not the study device.
Additional Manufacturer Narrative
Results of investigation: the available medical documents report a minimally displaced fracture of the proximal femur that was noticed after removing the broach number 2.This longitudinal fracture in the greater trochanter laterally progressed approximately 3 cm down the length of the femur and then turned posteriorly.This was secured with two cables.X-rays dated the day of surgery confirm the reported findings.The rasp was not returned for investigation.No deviations in the manufacturing records were detected for the stem and no information about broach was provided.Based on the available information, it is not possible to thoroughly investigate the reported issue.The root cause remains undetermined.No further actions have been initiated.
Event or Problem Description
It was reported a intraoperative periprosthetic fracture of right femur after removing broach 2, surgeon noted a longitudinal fracture approximately 3cm down the length of femur and then turned posteriorly.

• Brand Name: POLARSTEM STEM LAT.TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS,HIP,SEMI-CONSTRAIN, METAL/CERAMIC/POLY,CEMENT OR NON-POROUS,UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar, 06340 ; SZ 06340
• MDR Report Key: 7866712
• Report Number: 9613369-2018-00058
• Device Sequence Number: 11221462
• Product Code: LZO
• UDI-Device Identifier: 07611996118667
• UDI-Public: 07611996118667
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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 Expiration Date: 11/29/2024
• Device Catalogue Number: 75100475
• Device Lot Number: B1718645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 11/06/2018
• 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; Other
• Patient Age: 72 YR