MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.2

Model Number	01.12.022
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 february 2026.Stem: quadra-h 01.12.022 quadra stem standard hap 12/14 s.2 (k082792) lot 146367: (b)(4) items manufactured and released on 22-jan-2015.Expiration date: 31-dec-2019.No anomalies found related to the problem.To date, 50 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation; 11 years after primary cementless tha, the stem is mobilized.From the pre-revision image supplied, it is evident that the stem did not get proper proximal fixation and ended up stress-shielding the femur, and achieving only distal fixation.A possible reason for this event at long term, when the stem was properly implanted and likely also properly dimensioned, is the change of patient bone shape and density over the years - a main factor in determining long-term revisions.No reason to suspect a faulty or deteriorated device in this case.R&d analysis from the image attached to the complaint and the informations reported it is visible one side of the expianted stem.The stem is covered by patient blood.On the body part no ha residuals are visible.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.It is not possible to add more hypotesis without a visual inspection of the expianted part.Based on the analysis completed and information available, it is not possible to identify a root cause of the reported complaint.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
The patient reported mid-thigh pain and diagnostic tests revealed spaces around the stem.At about 10 years and 9 months after the primary, a revision surgery was performed due to stem loosening.The surgeon removed the stem with minimal effort.No signs of infection were observed.A competitor cemented stem was implanted.The ceramic liner was removed and replaced with a polyethylene liner, according to the surgeon`s preference.The cup remained in situ.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.2
• 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: 24588557
• Report Number: 3005180920-2026-00213
• Device Sequence Number: 13132926
• Product Code: JDI
• UDI-Device Identifier: 07630030802034
• UDI-Public: 07630030802034
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 03/13/2026

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: 12/31/2019
• Device Model Number: 01.12.022
• Device Lot Number: 146367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White