MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø44 MULTI-HOLE T

Model Number	01.32.144MHT
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary, during postoperative follow-up, the patient presented with pain, and loosening of the acetabular cup was detected.
Additional Manufacturer Narrative
Batch review performed on 19 january 2026.Cup: mpact 01.32.144mht acetabular shell d 44 multi-hole t (k230011) lot 2418538: (b)(4) items manufactured and released on 16-dec-2024.Expiration date: 28-nov-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.A few weeks after primary cementless tha, the female patient suffers acetabular mobilization and needs replacing the cup.The patient is small and her pelvis rather shalow, which may have made difficult achieving a good press-fit of the cup, that seems to be not touching the bone at the superior edge.In these conditions, during rehabilitation, an excessive stress may have triggered early mobilization, in spite of the screw that was implanted to support stability.No reason to suspect that a defective device originated this adverse event.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.In this case, the patient¿s small build and the shallow depth of the pelvis may have made it difficult to achieve a good press-fit of the cup; there appears to be not touching the bone at the superior edge, which, combined with excessive stress during rehabilitation, may have led to early mobilization despite the use of a stabilizing screw.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø44 MULTI-HOLE T
• 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: 24276569
• Report Number: 3005180920-2026-00079
• Device Sequence Number: 8569401
• Product Code: LPH
• UDI-Device Identifier: 07630345798664
• UDI-Public: 07630345798664
• Combination Product (Y/N): N
• PMA/510(K) Number: K230011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/06/2026

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 Model Number: 01.32.144MHT
• Device Lot Number: 2418538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2024
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian