MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED LAT STEM SIZE 3; HIP STEM

Catalog Number	01.18.243
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 sep 2024.Lot 180792: (b)(4) items manufactured and released on 19-june-2018.Expiration date: 2023-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a revision surgery was performed one and a half years after the primary implantation of a total hip arthroplasty (tha).The reported reason for the revision was stem loosening.The available x-ray image clearly shows radiolucent lines in the proximal part of the femoral stem, both medially and laterally.Determining the cause of this failure is challenging with the information currently available.Aseptic loosening is a well-documented complication following tha, and its causes are often unknown.Additionally, the image shows fixation implants for a pelvic fracture.The timing of this fracture is not reported, and it is unclear whether it may have contributed to the prosthetic failure.At this point, we do not have sufficient information to suspect a defective or malfunctioning device.
Event or Problem Description
At about 2 years 7 months after the primary, revision surgery due to stem loosening.All components were revised.

• Brand Name: STEM COLLARED HA COATED LAT STEM SIZE 3
• Common Device Name: HIP 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: 20341696
• Report Number: 3005180920-2024-00769
• Device Sequence Number: 7926555
• Product Code: LZO
• UDI-Device Identifier: 07630030804687
• UDI-Public: 07630030804687
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 10/01/2024

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: 06/12/2023
• Device Catalogue Number: 01.18.243
• Device Lot Number: 180792
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2018
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male