MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H FEMORAL STEMS; CEMENTLESS, HA COATED STD STEM SIZE 1

Model Number	01.12.021
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 october 2025, stem: quadra-h 01.12.021 cementless, ha coated std stem size 1 (k082792) lot 071431: (b)(4) items manufactured and released on 19-jul-2007.Expiration date: jun-2012.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.Clinical evaluation: almost 18 years after primary cementless tha the stem starts to give pain because progressive loosening is taking place.From the one radiograoh supplied, it appears that the progressive loss of bone density and loss of cortex thickness resulted eventually in stem mobilization.This is likely to happen because the patient&size39;s bone is likely to undergo significant changes over time, and the stem shape and dimension may no longer be the best for the new bone condition.No reason to suspect a faulty device as the cause of this revision surgery.Root cause:although a precise root cause cannot be established, it appears that the progressive loss of bone density and cortical thickness ultimately led to stem mobilization.This is likely to occur as the patient¿s bone undergoes significant changes over time.There is no indication that any potential issue with the device may have caused or contributed to the event, and the review of the device's history does not reveal any manufacturing-related issues.
Event or Problem Description
At about 17 years and 9 months from the primary, the patient came in due toa thigh pain for a stemquadra-h cementlessloosening.Dr hockings performed this revision through the anterior approach with no difficulties andreplaced the stem with anamis ccemented stem and the head with a ceramic 36 m.

• Brand Name: QUADRA-H FEMORAL STEMS
• Common Device Name: CEMENTLESS, HA COATED STD STEM SIZE 1
• 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: 23510671
• Report Number: 3005180920-2025-01074
• Device Sequence Number: 13286256
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 11/10/2025

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: 06/30/2012
• Device Model Number: 01.12.021
• Device Lot Number: 071431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2007
• 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