MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM LAT SIZE 10; CEMENTLESS HIP STEM

Model Number	01.36.070
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 april 2022.Lot 2101520: (b)(4) items manufactured and released on 07-jun-2021.Expiration date: 2026-may-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by clinical affairs specialist.Few weeks after a cementless tha, the patient reported a fracture.It was reported that the cerclage was inserted in order to prevent a fracture during femoral preparation.It is conceivable that during surgery, in particular during femoral preparation, the bone may have been weakened and a least-resistance area may have been created.Additionally, during rehabilitation period, a sudden movement on the weakened bone may favour the occurrence of early fracture.This is a known possible adverse event following tha and there is no reason to suspect that it is due to a defect in the implanted device or in the preparing instruments.
Event or Problem Description
At 2 weeks after the primary surgery, the patient femoral bone fractured.The femur fracture was not seen during surgery.The surgeon cabled in primary only because the stem was upsized.The fracture was only seen 2 weeks post-op.The surgeon is not planning to revise.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM LAT SIZE 10
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14191935
• Report Number: 3005180920-2022-00318
• Device Sequence Number: 14591672
• Product Code: LZO
• UDI-Device Identifier: 07630030888823
• UDI-Public: 07630030888823
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 05/20/2026
• Device Model Number: 01.36.070
• Device Catalogue Number: 01.36.070
• Device Lot Number: 2101520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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: Male