MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM C CEMENTED STD STEM SIZE 0; HIP STEM CEMENTED

Catalog Number	01.18.150
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22-dec-2023.Lot 154509: 21 items manufactured and released on 11-sep-2015.Expiration date: 2020-08-15.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medical affairs department revision 7 years and 7 months after primary tha due to cemented stem subsidence.From the low-quality images, radiolucent lines are visible in the medial part of the femur and we assume a preventive cerclage was applied during the index surgery, but no info was given.The subsidence of the stem is also highlighted by the radiolucent lines on the shoulder of the stem.The bone condition is extremely poor with very thin cortical's.We can suppose that bone quality was not good at primary surgery either because a cemented stem was chosen for a relatively young lady and cerclage, probably preventive, was applied.However, a plausible reconstruction of the events is that progressive impoverishment of the bone led the cement mantle to give way and not be able to substain the stem any longer.
Event or Problem Description
At about 7 years and 7 months after primary, the patient has been revised because of cemented stem subsidence.The surgery has been completed successfully.

• Brand Name: STEM: AMISTEM C CEMENTED STD STEM SIZE 0
• Common Device Name: HIP STEM CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18464995
• Report Number: 3005180920-2023-01091
• Device Sequence Number: 14244620
• Product Code: LZO
• UDI-Device Identifier: 07630030804250
• UDI-Public: 07630030804250
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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: 08/15/2020
• Device Catalogue Number: 01.18.150
• Device Lot Number: 154509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2015
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female