MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM QUADRA LATERIZED HAP 12/14 S4

Model Number	01.12.034
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation the complaint describes a late revision of a left cementless tha approximately 7 years and 7 months after primary implantation due to loosening of the femoral stem.The reported radiographic findings of proximal radiolucent lines, stress shielding at the greater trochanter, and femoral diaphyseal thickening are compatible with impaired long-term femoral fixation and altered load transfer.The most plausible clinical interpretation is late femoral stem loosening, likely aseptic based on the current documentation.The root cause cannot be definitively determined.Potential contributors include multifactorial loose of osseointegration, patient-related bone or loading factors, and biological remodeling.At present, there is no direct evidence confirming a manufacturing defect or intrinsic device malfunction.Batch review performed on 03 jun 2026 lot 174068: (b)(4) items manufactured and released on 15-nov-2017.Expiration date: 06-nov-2022.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause: based on the information available, no definitive root cause can be established.The event appears consistent with late femoral stem loosening, likely related to multifactorial clinical and biological factors affecting long-term fixation and load transfer.There is no indication that a manufacturing defect or intrinsic device malfunction caused or contributed to the reported event.
Event or Problem Description
Revision surgery due to stem loosening after about 7 years and 7 months from primary.Stem, head and liner revised.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM QUADRA LATERIZED HAP 12/14 S4
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25528750
• Report Number: 3005180920-2026-00559
• Device Sequence Number: 9744143
• Product Code: JDI
• UDI-Device Identifier: 07630030802164
• UDI-Public: 07630030802164
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: 11/06/2022
• Device Model Number: 01.12.034
• Device Lot Number: 174068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White