MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.4

Model Number	01.12.024
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had hip pain and infection.The x-ray suggested septic loosening of the stem.At about 9 years and 11 months post primary revision performed and the stem was removed with very minimal effort.
Additional Manufacturer Narrative
Batch review performed on 16 december 2025: lot: 153554: (b)(4) items manufactured and released on 26-sep-2015.Expiration date: 2020-oct-10.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Investigation performed by medacta hip r&d project manager: from the image and the information provided it is visible the explanted stem is covered with patient blood residuals.It seems that not ha coating remains on the stem body, meaning that the stem was correctly in contact with the patient & size 39 bone during the first years of implantation.Unfortunately, only one side of the stem is visible and for this reason, it is not possible to complete the analysis.The root cause of the stem loosening remains unknown.Clinical evaluation performed by medacta medical affairs director: 10 years after primary cementless tha an infection occurs and the femoral stem gets loose.The devices were apparently very well implanted and they must have served properly for 10 years.Secondary infections are a possible adverse event; they normally do not originate from the device area but can localize over the implant and create loosening.The implanted devices are not responsible for the onsert of this complication.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.4
• 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: 23886575
• Report Number: 3005180920-2025-01283
• Device Sequence Number: 4706608
• Product Code: JDI
• UDI-Device Identifier: 07630030802058
• UDI-Public: 07630030802058
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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): 12/23/2025

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: 09/26/2020
• Device Model Number: 01.12.024
• Device Lot Number: 153554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2015
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White