MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM QUADRA LATERIZED HAP 12/14 S1

Model Number	01.12.031
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 april 2026 lot 2001753: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 01-jul-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Five additional pieces (lot number 2001753a) were resterilized and released on 13-nov-2025 (expiration date 27-oct-2030), of which 3 have been sold with no similar reported event during the period of review.Clinical evaluation about 5 years after primary cementless tha, the stem is loose and requires revision.The stem looks correctly implanted.Only a-p xrays were provided, so no real evaluation of the correct sizing could be done, but the experience of the surgeon is such that an undersizing error is hardly imaginable.For unexplained reasons, the patient did not osteointegrate the implant, and the loosening is the inevitable consequence.There are no clues that we could identify to determine any other cause of this adverse event, which should probably be categorized as idiopathic aseptic loosening.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery due to quadra-h lat loosening about 5 years and 2 months after the primary surgery.The stem was easily removed with flexible osteotomes and a fabian hip removal tool.The stem appeared to have no ha coating on removal.Only stem and head revised, cup and hc pe liner not removed.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM QUADRA LATERIZED HAP 12/14 S1
• 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: 25160338
• Report Number: 3005180920-2026-00405
• Device Sequence Number: 10642556
• Product Code: JDI
• UDI-Device Identifier: 07630030802133
• UDI-Public: 07630030802133
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/13/2026

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: 07/01/2025
• Device Model Number: 01.12.031
• Device Lot Number: 2001753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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: Female