MAUDE Adverse Event Report: Medacta International SA Quadra H femoral stems; QUADRA Stem Quadra Laterized HAP 12/14 S5

Model Number	01.12.035
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 13 years 2 months from the primary, the patient came in due to loosening of the stem.The surgeon revised the quadra h stem to a quadra c stem.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 august 2026 stem: quadra-h 01.12.035 quadra stem quadra laterized hap 12/14 s5 (k082792) lot: 130165: (b)(4) items manufactured and released on 13-mar-2013.Expiration date: 28-feb-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 performed by clinical affairs department a revision surgery was performed 13 years after the primary tha due to femoral stem loosening.The available radiographic image confirms the reported event, showing areas of bone rarefaction around the proximal stem associated with radiolucent lines, findings compatible with loosening.Aseptic loosening is a well-documented complication of total hip arthroplasty and may have a multifactorial or unclear etiology.Given the long interval from primary implantation, multiple biological and mechanical factors may have contributed over time.Based on the limited information available, the precise mechanism leading to stem loosening cannot be determined.No definitive conclusion regarding the underlying failure mechanism can therefore be reached based on the available evidence.Root cause:aseptic loosening is 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 and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: Quadra H femoral stems
• Common Device Name: QUADRA Stem Quadra Laterized HAP 12/14 S5
• 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: 50543257
• Report Number: 3005180920-2026-00860
• Device Sequence Number: 21479877
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (Y/N): N
• PMA/510(K) Number: K082792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 02/28/2018
• Device Model Number: 01.12.035
• Device Lot Number: 130165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2013
• 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 Sex: Male
• Patient Weight: 264 LB
• Patient Race: White