MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø58 TWO-HOLES

Model Number	01.32.158DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 december 2025 cup: mpact 01.32.158dh acetabular shell d 58 two-holes (k132879) lot 2349379: (b)(4) items manufactured and released on 24-june-2024.Expiration date: 2029-06-10.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 01.32.3648hcat hooded pe hc liner d 36/f (k132879) lot 2429874: (b)(4) items manufactured and released on 03-jan-2025.Expiration date: 2029-12-09.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 01.29.208 mectacer head biolox delta dia.36 12/14-s (k112115) lot 2429386: (b)(4) items manufactured and released on 07-nov-2024.Expiration date: 2029-10-22.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.Stem: quadra-p collared 01.12.183 quadra-p collared lat.Size 3 (k192827) lot 2316543: (b)(4) items manufactured and released on 14-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.Screws: mpact 01.43.0020 cancellous bone screw d 6,5 l20 (k200391) lot 2413283: (b)(4) items manufactured and released on 01-july-2024.Expiration date: 2029-06-13.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.Screws: mpact 01.43.0025 cancellous bone screw d 6,5 l25 (k200391) lot.2319122: (b)(4) items manufactured and released on 06-sep-2023.Expiration date: 2028-08-20.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
Revision surgery at about 9 months after the primary due to infection.All components revised successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø58 TWO-HOLES
• 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: 23850112
• Report Number: 3005180920-2025-01282
• Device Sequence Number: 21286338
• Product Code: LPH
• UDI-Device Identifier: 07630030810893
• UDI-Public: 07630030810893
• 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): 12/19/2025

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: 01.32.158DH
• Device Lot Number: 2349379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2024
• 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: 80 YR
• Patient Sex: Male