MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.0

Model Number	01.12.020
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 february 2026.Stem: quadra-h 01.12.020 quadra stem standard hap 12/14 s.0 (k082792) lot 134341: (b)(4) items manufactured and released on 15-nov-2013.Expiration date: 31-oct-2018.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.Cup: mpact 01.32.048dh acetabular shell d 48 two-holes (k103721) lot 132788: (b)(4) items manufactured and released on 28-oct-2013.Expiration date: 30-sep-2018.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 at 12 years after primary cementless tha on a heavy and relatively young female patient, the stem subsides and needs revision.At the same time, the acetabular cup was revised too.The one picture supplied shows a clearly loose stem, with possible signs of osteolysis or osteolytic reaction all along the implant surface.The cause for this reaction after a long time in situ is not known; a succession of images could help in establishing the evolution of the problem.With the elements at hand, we cannot draw a definite conclusion.Root cause: aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.With the information available we cannot define a root cause, however, there is no indication that any potential issue with the device may have caused or contributed to the event.
Event or Problem Description
At about 11 years and 11 months from the primary, a revision surgery was performed due to loosening of themedacta mpact cup and quadra h stem.The surgery was completed successfully.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.0
• 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: 24454898
• Report Number: 3005180920-2026-00126
• Device Sequence Number: 9969222
• Product Code: JDI
• UDI-Device Identifier: 07630030802010
• UDI-Public: 07630030802010
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 02/26/2026

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: 10/31/2018
• Device Model Number: 01.12.020
• Device Lot Number: 134341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2013
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White