MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 3 NON-CEM; PROSTH, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEMENTED OR NON-POROUS, UNCEMEN

Model Number	75100466
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Hip Fracture (2349); Neuralgia (4413)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a revision surgery was performed on (b)(6) 2020 due to a broken neck of a polarstem size 3 that was initially implanted on (b)(6) 2018.Patient fell and broke little trochanter.
Additional Manufacturer Narrative
This complaint from belgium reports a fall that resulted in the broken neck of a polarstem stem ti/ha size 3.The device, which intent use is in treatment, was returned for investigation.The reported failure can be confirmed and a microscopic analysis was performed.About three quarter of the fracture surface show fatigue striations, indicating that the crack prpagated by fatigue.The residual fracture surface is covered by dimples, characteristics of ductile overload.No pores or inclusions, which could have initiated or enhanced crack growth, could be observed on the fracture surface.In the area of assumed crack initiation, scratches have been found which were likely present prior to fracture and may have led to this crack initiation.In our corresponding batch record and material certificate no deviations can be found, which could explain the occured neck breakage.The risk file review shows that the risk of implant fracture is low.For the reported batch number no other complaint can be found.One additional complaint was recorded which reports an implant fracture at the neck of this device.In our current ifu 12.23 ed.05/16 an implant fracture is a known risk which can occur.Three x-rays were provided to review.To date no medical records were submitted with this complaint.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.In conclusion, the root cause of the broken polarstem was likely the reported fall.Smith + nephew will monitor this device for similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 3 NON-CEM
• Common Device Name: PROSTH, HIP, SEMI-CONS, METAL/CERAMIC/POLY, CEMENTED OR NON-POROUS, UNCEMEN
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11194832
• Report Number: 9613369-2021-00039
• Device Sequence Number: 16319381
• Product Code: LZO
• UDI-Device Identifier: 07611996118575
• UDI-Public: 07611996118575
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 Expiration Date: 11/08/2024
• Device Model Number: 75100466
• Device Catalogue Number: 75100466
• Device Lot Number: B1717115
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/24/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR