MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 1 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED

Model Number 75100464

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/10/2020

Event Type  Injury  

Event Description

It was reported that a female patient had primary total hip replacment on the 19/8 at (b)(6) by dr (b)(6).As per his surgical tech for daa, no signs of fracture were present at the moment, but patient presented 1/52 later with pain.X-ray confirmed vancouver b2 fracture of femur.Patient underwent revision of femoral prosthesis to redapt 240 so stem with cables for orif of the fracture.

Manufacturer Narrative

It was reported that a patient had a primary total hip replacement due to a periprosthetic fracture.The reported article is a polarstem standard ti/ha stem size 1 [article no.: 75100464], which intent use is in treatment.The device was not sent back for investigation.A product history review was performed.No deviation was found in the corresponding batch record review, which would explain the reported bone fracture.Due to the clinical investigation and the x-ray review the bone fracture can be confirmed.Nevertheless, the root cause remains undetermined.In our corresponding instruction for use for hip implants 12.23 ed.05/16 bone fracture is a mentioned risk factor for a total hip endoprosthesis which can have several root causes.Should additional information got available the case can be re-opened.At the moment we are not assuming that the device failed in any way.S+n will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 10646156
• MDR Text Key: 210369171
• Report Number: 9613369-2020-00201
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: 07611996118551
• Combination Product (y/n): N
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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
• Device Operator: Health Professional
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B1913413
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention