MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT 3D METAL ACETABULAR SYSTEM; MPACT 3D METAL ACETABULAR SHELL Ø50 MULTI-HOLE THIN

Model Number	01.38.350MH
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07-mar-2025 lot 2416234: (b)(4) items manufactured and released on 11-sep-2024.Expiration date: 29-aug-2029.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 medical affairs manager: the available x-ray images clearly show a radiopaque, filament-like foreign body situated in the calcar region, just above the proximal femoral cut, and near the stem collar.Based on the picture available, the filament appears to be metallic in nature.However, it is challenging to determine the exact origin of the fragment from the available information.It seems unlikely that the fragment originated from the implanted devices or the specific instruments used for implantation, as no issues were reported during the surgery.Another possibility is that the fragment could have come from other tools used in the surgical procedure (such as a radiopaque marker in the surgical gauzes).Conducting a material analysis of the fragment would provide further clarity regarding its origin.Investigation performed by medacta hip r&d project manager: from the received information it was not possible to identify the wire-like metal fragment; as no screws were used during surgery, it is probable that it derived from other instruments used during surgery or from the threaded polar connection of the shell (derived from the shell or from the cup impactor instrument).However, a furthermore detailed analysis can be done if the piece is sent to medacta.D9 is yes, no devices have been explanted but we will receive the revised fragment.
Event or Problem Description
Revision performed in order to remove a wire-like metal fragment from the patient (devices have not been revised), found near to the stem collar, at about 15 days from primary.No screws have been used to secure the cup and also the shell plug has not been implanted.No issues have been detected with the instrument used during the impaction.
Additional Manufacturer Narrative
Data entered in the follow-up: - event description slightly modified.- external laboratory analysis performed in japan.- r&d evaluation based on the external laboratory analysis.Analysis from external laboratory in japan.The sample shows a metallic sheen with brown areas of oxidation and traces of organic material.Magnetism was confirmed.Qualitative element analysis: the main elements detected are cr (chromium) and fe (iron), with ni (nickel) and cu (copper) in smaller amounts, and mn (manganese), nb (niobium) and mo (molybdenum) in traces.The composition suggests that the sample came from stainless steel or similar materials.The analysis confirmed that the metal fragment contained chromium (cr) and iron (fe) as the main elements.Based on the elemental composition detected, it is suspected that they may have come from stainless steel or other steel materials.R&d analysis: if the material can be traced back to stainless steel (i.E.Steel, used for instruments and not for implants related to this complaint) and if the medacta instruments are flawless, it could be a piece of debris derived perhaps from standard (i.E.Non-medacta) pliers or retractors.These are suppositions, i don't have enough data to confirm my hypothesis.
Event or Problem Description
Additional surgery performed in order to remove a wire-like metal fragment from the patient (devices have not been revised), found near to the stem collar, at about 15 days from primary.During the primary no screws have been used to secure the cup and also the shell plug has not been implanted.No issues have been detected with the instrument used during the impaction.

• Brand Name: MPACT 3D METAL ACETABULAR SYSTEM
• Common Device Name: MPACT 3D METAL ACETABULAR SHELL Ø50 MULTI-HOLE THIN
• 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: 21695442
• Report Number: 3005180920-2025-00227
• Device Sequence Number: 15646950
• Product Code: LPH
• UDI-Device Identifier: 07630971212572
• UDI-Public: 07630971212572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K202568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/05/2025

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 Model Number: 01.38.350MH
• Device Lot Number: 2416234
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian