MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø56 MULTI HOLES

Model Number	01.32.156MH
Medical Device Problem Codes	Osseointegration Problem (3003); Unintended Movement (3026)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 february 2025.Lot: 2305777: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 2028-10-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional implant involved; batch review performed on 06 february 2025.Stem: quadra-p 01.12.143 quadra-p lat stem size 3 (k181254) lot: 2249410: (b)(4) items manufactured and released on 01-june-2023.Expiration date: 2028-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation performed by medical affair director.A revision surgery was performed one year after the primary total hip arthroplasty (tha) due to intrapelvic migration of the acetabular cup.The available x-ray images clearly confirm the intrapelvic migration of the acetabular component, which also appears rotated.Additionally, the femoral stem appears loose within the femur.As the postoperative x-ray is unavailable, we cannot assess the initial position of the prosthetic components.However, bone quality likely played a role, as it is reported to be poor.No history of trauma has been documented.Given the available information, we cannot draw definitive conclusions, but this failure does not appear to be due to a defective or malfunctioning device.
Event or Problem Description
The patient came in reporting pain due to the cup tearing through the acetabulum due to poor bone.The surgeon revised the stem and head with medacta components and revised the cup and liner to competitor components at about 1 year after the primary.The surgery was completed successfully.From the analysis of the x-rays, it was discovered also the loosening of the stem.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø56 MULTI HOLES
• 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: 21321318
• Report Number: 3005180920-2025-00031
• Device Sequence Number: 8063129
• Product Code: LZO
• UDI-Device Identifier: 07630030810862
• UDI-Public: 07630030810862
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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: 01.32.156MH
• Device Lot Number: 2305777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White