MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID SMS SOLID STEM STD SIZE 8; CEMENTLESS HIP STEM

Model Number	01.36.048
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 march 2020: lot 1901479: (b)(4) items manufactured and released on 28-may-2019.Expiration date: 2024-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director: few days after primary cementless tha the femoral stem subsides and requires revision.Although the primary postoperative xray was not supplied, it appears that a potential cause for subsidence was an undersized stem that could never find sufficient primary stability.Causes for undersizing are unknown.
Event or Problem Description
The patient came in reporting instability due to a subsided stem.About 1 month after primary surgery the surgeon revised the stem and ceramic head successfully.The surgery was completed successfully.The surgeon suspects that the subsidence occured due to an undersized stem being implanted during the primary.

• Brand Name: STEM: SMS SOLID SMS SOLID STEM STD SIZE 8
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9937359
• Report Number: 3005180920-2020-00232
• Device Sequence Number: 766439
• Product Code: LZO
• UDI-Device Identifier: 07630030888670
• UDI-Public: 07630030888670
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

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: 05/15/2024
• Device Model Number: 01.36.048
• Device Catalogue Number: 01.36.048
• Device Lot Number: 1901479
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: Required Intervention