MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA H FEMORAL STEMS; QUADRA STEM STANDARD HAP 12/14 S.5

Model Number	01.12.025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusions: the revision surgery has been performed following the implant breakage.Given the limited information was not possible to perform any investigation.
Event or Problem Description
Revision for stem neck breakage, no additional information available at the moment.Primary surgery data unknown.
Additional Manufacturer Narrative
Note: the exact primary surgery date is unknown.It could be (b)(6) 2019.R&d analysis after more than six years from implantation, a fracture occurred on the stem neck, requiring revision surgery.The removal of a biolox option head with its sleeve indicates that a previous revision surgery had already taken place; the reasons are still unknown.The biolox option and sleeve are typically used in cases where the stem is intended to be preserved.This assumption is further supported by the hospital invoicing records, which show that the stem and the head plus sleeve were not implanted on the same day.Further details are not available at the moment.The fracture occurred at the prosthesis neck.Several surface damages, such as scratches and localised discolourations, were observed across the fracture area, on both the stem and head sides.It is unclear whether these alterations originated during the primary surgery or subsequent revisions.It can be stated, however, that the mechanical fatigue fracture was likely triggered by these surface alterations on the stem neck.Interaction with a high-density energy source (e.G., an electrosurgical knife) or accidental high-energy contact with hard surgical instruments may have caused burns or scratches.These anomalies act as stress concentrators and material discontinuities, capable of propagating a crack under load through a fatigue mechanism.It is therefore plausible that the stem neck was accidentally struck by an electrically charged instrument, creating an initiation site that, over time, led to the fracture of the neck.In conclusion, the prosthesis failure can be attributed to the fatigue propagation of a crack initiated by surface damage, caused either by highly localized heat exposure or by accidental impact to the stem.Batch review performed on 20 august 2025: lot 184779: (b)(4) items manufactured and released on 08 nov 2018.Expiration date: 29 oct 2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events since the lot was released.Conclusions: although no definitive root cause can be established, it is highly probable that the neck of the stem became damaged at the surface, possibly by interaction with a power source (i.E.Electrosurgical knife) or high-energy contact with hard objects (e.G.Surgical instruments).This is a plausible mechanism to create a microcrack in the neck, which is likely to be the origin of a fatigue fracture.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.
Event or Problem Description
Revision surgery performed due to stem neck breakage after about 6 years and 5 months.The patient had an intermediate surgery between the primary and the revision of (b)(6) 2025 (date unknown, reason unknown) in which the head has been revised.We have this evidence because the revised head on (b)(6) 2025 is a revision head; we don't know if other implants were revised.

• Brand Name: QUADRA H FEMORAL STEMS
• Common Device Name: QUADRA STEM STANDARD HAP 12/14 S.5
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22749123
• Report Number: 3005180920-2025-00749
• Device Sequence Number: 15842306
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 10/29/2023
• Device Model Number: 01.12.025
• Device Lot Number: 184779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2018
• 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: Unknown