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

Model Number 75100464

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

Patient Problem Bone Fracture(s) (1870)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Complaint reference: (b)(4).

Event Description

It was reported that revision surgery was performed due to femur fracture on (b)(6) 2020, in which a polarstem sz1 stem and oxinium head 32mm -3 were implanted.Fracture was reduced using 2 x cables and polarstem and oxinium femoral head were exchanged for edapt stem 190mm x 15mm and 32mm +0 cobalt chrome head.Procedure was completed with no complications.

Manufacturer Narrative

Results of investigation: a post-operative femur fracture was reported.The fracture was reduced using cables and the initial implanted polarstem stem standard ti/ha size 1 was exchanged, as well as the oxinium femoral head.The claimed stem, which intent use is in treatment, was not returned for investigation.The specific batch record was reviewed.There were no rejected parts in this batch, every part was manufactured and released according to our specifications.For the reported batch number no other complaint can be found.At that time of investigation the root cause remains undetermined.In our current instruction for use for hip implants 12.23 ed.05/16 a bone fracture is a known risk.The risk file review shows that this risk remains as anticipated.Internal complaint reference number: case (b)(4).

• Brand Name: POLARSTEM STEM STD TI/HA 1 NON-CEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11022905
• MDR Text Key: 221865751
• Report Number: 9613369-2020-00261
• Device Sequence Number: 1
• Product Code: LWJ
• 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: 02/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 75100464
• Device Catalogue Number: 75100464
• Device Lot Number: B2004209
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 71343203, LOT 20BM20944; HEAD 71343203, LOT 20BM20944
• Patient Outcome(s): Hospitalization; Required Intervention