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

Model Number 75100464

Device Problem Loss of Osseointegration (2408)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/12/2017

Event Type  Injury  

Event Description

Revision surgery left hip due to periprosthetic fracture at the base of the polarstem stem.Injury sustained from a fall.The acetabulum components (r3 cup, xlpe liner) remains in situ.

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL, CEMENTED OR NON-POROUS, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; oberneuhofstrasse 10d; baar 6340 ; SZ 6340
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau 5001 ; SZ 5001
• Manufacturer Contact: markus poettker
• MDR Report Key: 6819766
• MDR Text Key: 83604464
• Report Number: 9613369-2017-00045
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07611996118551
• UDI-Public: (01)07611996118551(17)230726(10)B1611523
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130728
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2023
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B1611523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2017
• Date Device Manufactured: 07/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OXINIUM FEMORAL HEAD, PART 71343600, LOT 17BM01233
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR