MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 6 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100479
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint reference: case-(b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
It was reported that during a total hip replacement procedure the femur was milled with a reamer 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 a reamer 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 positioning failure will be evaluated, due to the assumption, that this is the cause for the periprosthetic fracture.The first implanted polarstem stem lat.Ti/ha 6 non-cem, which intent use is in treatment, was not returned for investigation.A product history review did not reveal any deviation which could explain the occurred positioning failure.Neither for the reported batch number, nor for the specific article a similar complaints was reported since recording.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: POLARSTEM STEM LAT.TI/HA 6 NON-CEM
• Common Device Name: 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: 11009135
• Report Number: 9613369-2020-00258
• Device Sequence Number: 3595056
• Product Code: LWJ
• UDI-Device Identifier: 07611996118704
• UDI-Public: 07611996118704
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 75100479
• Device Catalogue Number: 75100479
• Device Lot Number: B2008204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention