MAUDE Adverse Event Report: SMITH & NEPHEW, INC. POLARSTEM STEM STD TI/HA 2 NON-CEM; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number	75100465
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after primary surgery (thr), the patient had a lesser trochanter fracture which caused the implant to sink.Unknown cause of the fracture.The surgeon did not believe the fracture to be caused by the device.Backup from smith&nephew was available.All x-rays and medical records available have been attached.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
A lesser trochanter fracture was reported after primary surgery.A polarstem stem std ti/ha 2 non-cem had been implanted, which intent use is in treatment.The product was not returned for investigation furthermore it is not known if the stem was explanted.The product history review reveal no deviations which could explaine the bone fracture.It will not be assumed that the product did not function as intended.Based on the documentation provided, although the x-ray supports the complaint, the root cause of the reported events could not be definitively concluded.However, an unrecognized intraoperative fracture, trauma postop, and/or thinning of the cortex cannot be ruled out as possible contributing factors to the reported events.The patient impact beyond the reported periprosthetic fracture, stem subsidence and revision could not be determined.No further medical assessment can be rendered at this time.In our current instruction for use for hip implants 12.23 ed.05/16 bone fracture is a known and possible side effect of a total hip replacement (ter) and is covered in our specific risk file.At that time of investigation the root cause can not be determined and s+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 2 NON-CEM
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10492206
• Report Number: 1020279-2020-04386
• Device Sequence Number: 2828205
• Product Code: JDG
• UDI-Device Identifier: 07611996118568
• UDI-Public: 07611996118568
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 10/19/2020

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 Model Number: 75100465
• Device Catalogue Number: 75100465
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71332530X2, 71335550-4950-6500, 71342800 75100465,; 71332530X2, 71335550-4950-6500, 71342800 75100465,
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention