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

Model Number	01.32.156DH
Medical Device Problem Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 october 2025 screws: impact 01.43.0040 cancellous bone screw ø 6,5 l40 (k200391) lot 2109268: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 21-oct-2026.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.Screws: impact 01.43.0020 cancellous bone screw ø 6,5 l20 (k200391) lot 2218850: (b)(4) items manufactured and released on 19-oct-2022.Expiration date: 28-sep-2027.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.Cup: impact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot 2420493: (b)(4) items manufactured and released on 14-nov-2024.Expiration date: 28-oct-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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
About 3 months after the primary surgery, the patient came reporting pain due to a loose cup.The surgeon revised the cup, screws (one was found broken), head, and liner to a competitor's product.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 15 october 2025.Screws: mpact 01.43.0040 cancellous bone screw ø 6,5 l40 (k200391) lot 2109268: (b)(4) items manufactured and released on 04-nov-2021.Expiration date: 21-oct-2026.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.Screws: mpact 01.43.0020 cancellous bone screw ø 6,5 l20 (k200391) lot 2218850: (b)(4) items manufactured and released on 19-oct-2022.Expiration date: 28-sep-2027.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.Cup: mpact 01.32.156dh acetabular shell ø56 two-holes (k132879) lot 2420493: (b)(4) items manufactured and released on 14-nov-2024.Expiration date: 28-oct-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 by our clinical affairs director.Three months after primary cementless tha, the acetabular cup demonstrated significant mobilization despite fixation with two bone screws.No traumatic event was reported, although such a degree of mobilization would typically be associated with trauma.The cup failed to achieve secondary fixation through bone ongrowth and therefore required revision.There is no evidence to suggest a device-related failure.The event was most likely caused by either an unreported minor traumatic event or insufficient bone ongrowth at the implant-bone interface.Conclusion: although a precise root cause cannot be established, the cup failed to achieve secondary fixation, likely due to insufficient bone ongrowth at the implant-bone interface or as a consequence of a minor traumatic event not reported in the complaint.There is no indication that any device-related issue caused or contributed to the event, and the review of the device history record did not identify any potential manufacturing-related issues.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø56 TWO-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: 23434514
• Report Number: 3005180920-2025-01050
• Device Sequence Number: 20989043
• Product Code: LZO
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• 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: 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): 12/23/2025

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: 01.32.156DH
• Device Lot Number: 2420493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2024
• 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 Sex: Unknown