MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM STD TI/HA 3 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Model Number	75100466
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a hip surgery had been performed on (b)(6) 2020 the patient suffered recent fall and fractured femur.The adverse event was addressed with a revision surgery on (b)(6) 2021 to replace the polarstem stem std ti/ha 3 non-cem and oxonium fem hd 12/14 36 mm l/+8.The condition of the patient is unknown.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed a fracture of the femur, from which the patient suffered after a fall.The device, used in treatment was not returned for evaluation, therefore further analysis was not possible.Therefore, the relationship between the reported event and the device cannot be confirmed.However, based on the communicated information, the product history could be reviewed.The production documentation was reviewed.There are no indications that the part failed to match specification at the time of manufacturing.There were no further complaints reported for the batch in scope.The failure mode and the severity are covered through the corresponding risk management files.The ifu lit.No.12.23, ed.05/16 lists bone fracture as a possible side effect.A medical investigation concludes that the femoral fracture and the subsequent revision were a result of the patient's fall.The issue is not associated with a mal-performance of the device.The root cause of the femoral fracture is associated with the patients fall and not with a malperformance of the implant.To date, further actions are not deemed necessary.Should additional information become available, this complaint will be reassessed.Smith and nephew will monitor this device for further similar issues.

• Brand Name: POLARSTEM STEM STD TI/HA 3 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: 11872784
• Report Number: 9613369-2021-00262
• Device Sequence Number: 3269291
• Product Code: LWJ
• UDI-Device Identifier: 07611996118575
• UDI-Public: 07611996118575
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 75100466
• Device Catalogue Number: 75100466
• Device Lot Number: B1816125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 07/09/2021
• 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