MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STD STEM SIZE 4; HIP CEMENTLES STEM

Model Number	01.18.134
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-op x-rays revealed radiolucent lines and stem sinking, more than 2 years after the primary.The bone above the lesser trochanter is missing.The surgeon is evaluating a possible revision surgery.
Additional Manufacturer Narrative
Bach review performed on 12-may-2023lot 182770: (b)(4) manufactured and released on 03-aug-2018.Expiration date: 2023-07-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by meadacta medical affairs manager: according to report, during a follow up visit more than 2 years after the index tha surgery, it was revelead from the radiograhic images that the stem subsided and radiolucent lines were visible.Surgeon is evaluating a possible revision surgery.The radiographic history shows a progressive development of proximal radiolucent lines and a potted stem at 1 year.Subsequently, subsidence occurred and it is not known if a reliable stability has been achieved.The reason of this failure cannot be determined but there is no reasons to suspect a malfunctioning device.

• Brand Name: AMISTEM H, HA COATED STD STEM SIZE 4
• Common Device Name: HIP CEMENTLES STEM
• 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: 17029861
• Report Number: 3005180920-2023-00403
• Device Sequence Number: 7030266
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/31/2023

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: 07/24/2023
• Device Model Number: 01.18.134
• Device Catalogue Number: 01.18.134
• Device Lot Number: 182770
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2018
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian