MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG UNKN. POLARSTEM CEMENTLESS (TI/HA); REAMER

Catalog Number UNKNOWN

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

Patient Problem Hip Fracture (2349)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a thr procedure the femur was milled with a reamer 6 and when they tried to place a stem 6l was 1cm outside the femur.Then, surgeon milled with a reamer 7, but not completely, and tried to put the stem 6 back but it was still 5mm outside.Dr.Opened a new 6l stem and it was a perfect fit.In this process, a peri-prosthetic fracture occurred near the calcar femoral and it was necessary to put a wire cerclage.With this process the surgery took extra 15 minutes, until the use of the new definitive femoral stem.

Manufacturer Narrative

Results of investigation: it was reported that during a total hip replacement procedure the femur was milled with an unknown polarstem hip instrument size 6 and by trying to place a polarstem stem lat.Ti / ha 6 non-cem, it was 1cm outside the femur.Then, surgeon milled with an unknown polarstem hip instrument size 7, but not completely, and tried to put the stem back but it was still 5mm outside.By opening a new polarstem stem lat.Ti / ha 6 non-cem, it fit perfectly.In this process, a peri-prosthetic fracture occurred near the calcar femoral and it was necessary to put a wire cerclage.The provided image supports the seating of the second stem and confirmation of the wiring as a result of the reported intra-operative fracture.In this case the unknown polarstem hip instrument and the positioning failure will be evaluated.To date neither the reported unknown polarstem hip instrument was returned for investigation nor the specific article or batch number was communicated.A thorough product evaluation and product history review could not be performed.The root cause for this case remains undetermined.In our current ifu for hip implants on (b)(6) ed.On (b)(6), there are several indications which could explain the reported failure and the failed positioning of the stem e.G.Unsuitable choice of implant size, inadequate cleaning of the bone bed before implantation etc.The risk of a fit / sizing problem is covered in our corresponding risk management file.However smith and nephew has not received adequate materials, like surgery report or the claimed product itself, to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.

• Brand Name: UNKN. POLARSTEM CEMENTLESS (TI/HA)
• Type of Device: REAMER
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11009151
• MDR Text Key: 221476152
• Report Number: 9613369-2020-00259
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• 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: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention