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 Problems Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 10/01/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening and severe pain.After primary revision surgery, a fracture of the stem was noticed under x-rays examination.Preservation therapy to give pressure on the bone was performed.Additionally, head and liner were revised.

Event Description

It was reported that on (b)(6) 2019, a primary surgery was performed.One week after surgery, x-ray resulted in a fracture around the stem (vancouer a).Conservation treatment by load and lipus started.Full load started on (b)(6).After that the sinking and loosening started and conducted to revision of stem was operated on (b)(6) 2019.

Manufacturer Narrative

A revision surgery was reported due to bone fracture one week post implantation and consequential implant loosening.A polarstem cementless stem ti/ha std 1, used in treatment, was explanted but not returned for investigation.No medical documentation or x-rays have been provided to assist with a clinical investigation.Furthermore no product was returned.The batch record review reveals no deviation which could relate to the reported failure mode.Furthermore no other complaint can be found for the reported batch number.Therefore it can not be assumed that the fracture occurred due to a false or wrong manufactured product.Bone fracture is by the way a known side effect and is described in the ifu lit.No.12.23 ed.05/16.Nevertheless, the risk of this failure to occure is considered to be low and is justifiable by s+n.In conclusion, the root cause of the femur fracture cannot be definitively concluded with the information provided or with the done investigations.It will be assumed that the bone was damaged due to the implantation but without supporting clinical/medical documents no clear root cause can be identified and the root cause remains undetermined.If further information will be available the complaint will be re-assessed.

• 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; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 9568314
• MDR Text Key: 174273447
• Report Number: 9613369-2020-00007
• 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,Followup
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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: B1908036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEAD 71343204, LOT 19EM01482; LINER 71339550, LOT 18MM09098; HEAD 71343204, LOT 19EM01482; LINER 71339550, LOT 18MM09098
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 58