MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STANDARD TI/HA 4 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED

Model Number	75100467
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Stem subsidence owing to fracture at calcar and greater trochanter surgeon dissected down to hip joint.Dislocated hip.Removed stem and bipolar head as one construct using the polarstem removal tool prepared canal for echelon cemented stem cemented size 14 175mm echelon stem std collar.Trialed bipolar head and hip deemed stable.Inserted definitive bipolar construct onto stem.Reduced hip.Reduced gt fracture and fixated with periprosthetic plate.
Event or Problem Description
Revision surgery performed due to fracture of the greater trochanter and stem subsidence.

• Brand Name: POLARSTEM STEM STANDARD TI/HA 4 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• MDR Report Key: 7329679
• Report Number: 9613369-2018-00014
• Device Sequence Number: 160499
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2018

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: 07/12/2024
• Device Model Number: 75100467
• Device Catalogue Number: 75100467
• Device Lot Number: B1710517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 02/08/2018; 02/08/2018
• Initial Report FDA Received Date: 03/10/2018
• Supplement Report FDA Received Date: 03/12/2018; 05/17/2018
• 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