MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. POLARSTEM CEMENTLESS STEM LAT TI.HA 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	75100479
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a fall post op and now presents with peri prosthetic fracture.
Additional Manufacturer Narrative
Results of investigation: a complaint was reported due to a post-operative peri-prosthetic fracture.No part was returned for investigation.A review of the production documentation did not detect any deviation from the standard manufacturing processes.No other complaints were reported for this batch of devices.The provided x-rays confirm the femoral bone fracture on the lateral side of the distal third of the femoral stem.This fracture occurred maximally 3 weeks after the implantation.As no information on the implantation, the immediate post-operative situation was provided further assessment on the reason for this fracture cannot be performed.Based on the performed investigation the root cause remains undetermined.There is no indication that the device failed to match specification at the time of manufacturing.No further actions have been initiated.

• Brand Name: POLARSTEM CEMENTLESS STEM LAT TI.HA 6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar TN 06340 ; SZ 06340
• MDR Report Key: 8051509
• Report Number: 1020279-2018-02407
• Device Sequence Number: 1786657
• Product Code: LZO
• UDI-Device Identifier: 07611996118704
• UDI-Public: 07611996118704
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: No Information
• Device Expiration Date: 04/03/2024
• Device Catalogue Number: 75100479
• Device Lot Number: B1705173
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/12/2019
• 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 Age: 86 YR