MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARSTEM STEM LAT.TI/HA 5 NON-CEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	75100478
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a thr surgery conducted on (b)(6) 2022, a patient suffered a fracture of left trochanter.It is unknown whether this occurred while positioning the polarstem stem lat.Ti/ha 5 non-cem stem implant or during femoral preparation prior to the implant insertion.It is unknown if this incident provoked a surgical delay.This adverse event was resolved with cables during surgery.The patient's current health status is recovering and resolving.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: it was reported that, during a total hip replacement surgery conducted on 9-jun-2022, a patient suffered a fracture of left trochanter.The device, used in treatment, was not returned for investigation.A product evaluation could therefore not be performed.A review of the complaint history of the affected device was performed.No additional complaints for the batch in question were detected.Furthermore, a review of the production documentation, was performed and no deviations were detected, 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.The limited information was insufficient to complete a thorough medical assessment of the root cause and patient impact beyond the reported events.The risk of bone fracture is covered in our corresponding risk file and rated as low.In the current instruction for use for hip implants lit.12.23 ed.03/21, hip fracture is stated as a potential adverse device effect in combination with the placement of a hip implant.Based on our investigations, the failure mode cannot be confirmed.Due to insufficient information it is not possible to speculate about factors which could have contributed to the reported event and the root cause of the problem remains undetermined.A relationship between the reported event and the device cannot be confirmed.To date, no further actions will be taken.Smith and nephew will monitor the devices for further similar issues.Should additional information become available, this complaint will be reassessed.This investigation is considered closed.

• Brand Name: POLARSTEM STEM LAT.TI/HA 5 NON-CEM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 15090634
• Report Number: 9613369-2022-00458
• Device Sequence Number: 3879023
• Product Code: LZO
• UDI-Device Identifier: 07611996118698
• UDI-Public: 07611996118698
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130728
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 05/27/2026
• Device Model Number: 75100478
• Device Catalogue Number: 75100478
• Device Lot Number: B1911732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 07/24/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OXINIUM FEM HD 12/14 32MM +0, LOT#:21LM00077; R3 20 DEG XLPE ACET LNR 32MM X 48MM, LOT#:21HM2179; R3 3 HOLE ACET SHELL MM48, LOT#:21CW12495
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 57 KG