MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA "H" SHORT NECK, CEM.LESS, LAT., HAP S.3

Model Number	01.12.33SN
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 november 2025.Stem: quadra-h 01.12.33sn quadra h short neck, cementless, lat., hap s.3 lot 164570: (b)(4) items manufactured and released on 04-nov-2016.Expiration date: 17-oct-2021.No anomalies found related to the problem.To date, 29 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation 6 years after revision tha, the stem gets loose again and further revision is necessary.We have been given only one pre-revision image.The stem looks radiologically loose, perhaps slightly undersized (but this cannot be stated unless the post-surgery xrays in two planes are made available), and we cannot determine the cause.In absence of infection, we must classify this event as an idiopathic aseptic loosening, a possible adverse event following tha, described in literature, whose causes often remain undtermined.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
On (b)(6) 2018, the patient had primary right hip surgery.On (b)(6) 2019, the patient came in complaining of pain caused by a loose stem.The surgeon revised the stem and head and the surgery was completed successfully (mdr (b)(4)).Presently, on (b)(6) 2025, the patient came in due to pain caused by a loose stem and the cause is unknown.The surgeon revised the medacta head and stem to a competitor head and stem and revised the medacta liner to a medacta liner.The surgery was completed successfully.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA "H" SHORT NECK, CEM.LESS, LAT., HAP S.3
• 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: 23836915
• Report Number: 3005180920-2025-01229
• Device Sequence Number: 14722694
• Product Code: JDI
• UDI-Device Identifier: 07630030802737
• UDI-Public: 07630030802737
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/18/2025

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: 10/17/2021
• Device Model Number: 01.12.33SN
• Device Lot Number: 164570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2016
• 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 Sex: Female