MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 0 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,UNCEMENTED

Model Number	75100463
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.Patient fell over and fractured her femur.Fracture extended down the lesser trochanter.Polar stem and head were removed and 2 cables inserted to repair fracture and redapt stem inserted.
Additional Manufacturer Narrative
It was reported that revision surgery of a polarstem (75100463) was performed due to periprosthetic fracture of the lesser trochanter after the patient fell.The device used in treatment was not returned for investigation.To date no medical records have been received.Without any supporting medical documentation, the reported event could not be assessed, and a thorough medical assessment could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint reported for a similar issue for the in scope device.The ifu (lit.No.12.23 ed.05/16) identifies bone fracture as a known possible side effect resulting from a total hip arthroplasty.However, there is no indication that the device failed to match specification at the time of manufacturing.The associated risk is covered in the risk analysis and considered low.Based on the information available, the fracture is considered to be the result of the reported fall.There is therefore no product defect assumable.Smith + nephew will continue to monitor this device for similar issues.The complaint will be reopened should the complained device or additional information be received.

• Brand Name: POLARSTEM STEM STD TI/HA 0 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER,UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9630679
• Report Number: 9613369-2020-00016
• Device Sequence Number: 3445519
• Product Code: LZO
• UDI-Device Identifier: 07611996118544
• UDI-Public: 07611996118544
• 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 Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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 Expiration Date: 03/27/2026
• Device Model Number: 75100463
• Device Catalogue Number: 75100463
• Device Lot Number: B1906985
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1