MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM CEMENTLESS STEM LAT TI.HA 2; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	75100475
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient experienced hypoxia while sleeping in post-anesthesia care unit.The event required to extend hospitalization to get it resolved on (b)(6) 2019.This is unrelated to the device but possibly related to the procedure.
Additional Manufacturer Narrative
This is a complaint submitted from the odh study for subject (b)(6).The patient suffered ¿hypoxia¿ post primary surgery.The used implant is a polarstem cementless stem lat.Ti/ha 2.Several attempts have been made to obtain more clinical/medical documents.Without supporting clinical/medical documents a thorough investigation cannot be performed.A complaint history and batch record review reveal no abnormalities.There is no indication that the implanted device didn't match specification at time of manufacturing.Should information become available this complaint can be re-assessed.The root cause stays undetermined.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 2
• 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
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH500 0; SZ CH5000
• Manufacturer Contact: sarah freestone ; oberneuhofstrasse 10d; baar 06340 ; SZ 06340 ; 0447940038246
• MDR Report Key: 9167871
• Report Number: 9613369-2019-00076
• Device Sequence Number: 3885097
• Product Code: LZO
• UDI-Device Identifier: 07611996118667
• UDI-Public: 07611996118667
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

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: 02/03/2026
• Device Model Number: 75100475
• Device Catalogue Number: 75100475
• Device Lot Number: B1902672
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 11/14/2019; 12/23/2021
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/21/2019; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEAD 76539165, LOT 75DT19453; LINER 71332756, LOT 19DM19144; SHELL 71335556, LOT 19CW20130
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 124 KG