MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM COLLAR LAT. TI/HA 10; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Catalog Number	75102210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery due to proximal femoral shaft fracture.Stem and femoral head replaced.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed, due to proximal femoral shaft fracture.The surgeon decided to revise the polarstem collar lat ti/ha size 10 (75102210).The explanted stem was not returned for evaluation.Additionally no further medical information were provided, therefore no thorough medical assessment could be performed.The production documentation was reviewed, there could be no deviation found from standard procedures.There were no other complaints reported for the product in scope.Based on the information provided the failure mode cannot be confirmed.The root cause cannot be determined due to insufficient information.Should further information or to product become available this complaint will be reopened and reassessed.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM COLLAR LAT. TI/HA 10
• 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: 9216040
• Report Number: 9613369-2019-00078
• Device Sequence Number: 10859657
• Product Code: LZO
• UDI-Device Identifier: 07611996152708
• UDI-Public: 07611996152708
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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: Health Professional
• Device Expiration Date: 05/13/2025
• Device Catalogue Number: 75102210
• Device Lot Number: B1808724
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 12/09/2019
• 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: HEAD: 71343612, LOT 15FM19145
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention