MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM CEMENTLESS STEM STD TI.HA 4; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100467
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject presented a calcar fracture.This fracture was discovered after the surgery upon checking x rays.The event is being attributed to the implanting of the stem.The fracture was treated via cerclage wire.The subject is recovering positively and the implant is more stable than before.
Additional Manufacturer Narrative
It was reported that a patient presented a calcar fracture.According to the complainant, the fracture was treated with cerclage wire.Therefore, the polarstem (75100467) intended for use in treatment was not returned for investigation.The device could therefore not be evaluated and the stated failure mode not independently be confirmed.To date no medical/clinical documentation has been provided.Without any supporting medical documentation, a thorough medical assessment could not be performed.A review of the batch record revealed no deviations from the standard manufacturing process.The ifu (lit.No.12.23 ed.05/16) identifies bone fracture as a known possible side effect resulting from a tha.A review of the complaint history revealed three similar complaints reported for the device in question.However, there is no indication that the device did not meet specification at the time of manufacturing and the failure mode and severity are covered in the risk file.Based on available information the root cause for the reported periprosthetic fracture cannot identified and stays undetermined.The need for corrective action is not deemed necessary.Nevertheless, smith and nephew will continue to monitor the device for similar issues.The complaint will be reopened should additional information be received or the a revision surgery take place.

• Brand Name: POLARSTEM CEMENTLESS STEM STD TI.HA 4
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; baar 06340 ; SZ 06340
• MDR Report Key: 9885099
• Report Number: 9613369-2020-00073
• Device Sequence Number: 19469590
• Product Code: LZO
• UDI-Device Identifier: 07611996118582
• UDI-Public: 07611996118582
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 06/03/2025
• Device Model Number: 75100467
• Device Catalogue Number: 75100467
• Device Lot Number: B1804516
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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
• Patient Weight: 89