MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM VALGUS TI/HA 4; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Model Number	75102076
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during total hip replacement, the patient experienced an intraoperative femur fracture.This adverse event was treated by an intraoperative open reduction bone repair.Surgery was completed with the same devices.It is unknown if there was a delay.Patient's current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during total hip replacement, the patient experienced an intraoperative femur fracture.This adverse event was treated by an intraoperative open reduction bone repair.Surgery was completed with the same devices.It is unknown if there was a delay.Patient's current health status is unknown.The device, intended for use in treatment, was not returned for visual inspection.A complaint history review regarding the batch in question was performed.No further complaints were detected.The review of the product documentation did not detect any deviation that could have contributed to the reported failure mode.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of past corrective actions was performed.No further escalation is required.A review of the risk management documentation has been conducted.The occurence and severity are in line with the corresponding risk file.Furthermore, a review of the device labelling reveals that the instructions for use document (lit.No.Lit.No.12.23, ed.03/21) indicates that "application of excessive pressure when placing or fixing the implant can provoke fractures of bone damage" as an ¿intraoperative" surgical step in combination with the implantation of a hip prosthesis.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event.We remind to follow our document "surgical technique, polarstem, cementless and cemented stem system (lit.No° 01217-en (1513) v4 01/16)" to prevent any undesirable side effects.Smith and nephew will continue to monitor this device for similar issues.No further actions are deemed necessary at this point.This investigation is considered as closed.

• Brand Name: POLARSTEM VALGUS TI/HA 4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15519256
• Report Number: 9613369-2022-00519
• Device Sequence Number: 14966427
• Product Code: MEH
• UDI-Device Identifier: 07611996142365
• UDI-Public: 07611996142365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 06/20/2024
• Device Model Number: 75102076
• Device Catalogue Number: 75102076
• Device Lot Number: B1709310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown