MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø60 NO-HOLE

Model Number	01.32.160SH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 may 2026 cup: mpact 01.32.160sh acetabular shell d 60 no-hole (k132879) lot.2507409: (b)(4) items manufactured and released on 02 june 2025.Expiration date: 15 may 2030.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.Liner: mpact 01.32.3252hct flat pe hc liner d 32/g (k103721) lot.2344538: (b)(4) items manufactured and released on 05 december 2023.Expiration date: 20 november 2028.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.Ball heads: mectacer 01.29.204 mectacer head biolox delta dia.32 12/14-s (k112115) lot.2522147: (b)(4) items manufactured and released on 15 september 2025.Expiration date: 28 august 2030.No anomalies found related to the problem.To date, 43 items of the same lot have been sold, with no similar reported events during the period of review.Stem: amistem p 01.18.414 amistem-p lat.Size4 (k173794) lot.2305076: (b)(4) items manufactured and released on 06 june 2023.Expiration date: 17 may 2028.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.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
After primary surgery on (b)(6) 2025, the patient underwent revision surgery on (b)(6) 2025 due to infection.A puncture/aspiration was subsequently performed on (b)(6) 2026.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø60 NO-HOLE
• 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: 25442531
• Report Number: 3005180920-2026-00560
• Device Sequence Number: 5726148
• Product Code: LPH
• UDI-Device Identifier: 07630030810961
• UDI-Public: 07630030810961
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 01.32.160SH
• Device Lot Number: 2507409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2025
• 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: 62 YR
• Patient Sex: Male