MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES

Model Number	01.32.152DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient presented with pain due to a dislocation.The surgeon revised the femoral head and liner.On (b)(6) 2024, the patient came in reporting infection.Imaging showed an anteverted cup, with no signs of periprosthetic fracture.No implants were removed.On (b)(6) 2025, the patient had a new dislocation successfully treated.No implants were removed.During the week of (b)(6) 2025, the patient presented with pain due to a dislocation.The surgeon then identified an infection, which was the unique reason for the revision.All implants were removed, an osteotomy was performed, and an antibiotic spacer was inserted.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 july 2025 cup: mpact 01.32.152dh acetabular shell ø52 two-holes (k132879) lot.2342592: (b)(4) items manufactured and released on 27-02-2024.Expiration date: 13-02-2029.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: stem: amistem p 01.18.402 amistem-p std.Size2 (k173794) lot.2308177: (b)(4) items manufactured and released on 20-07-2023.Expiration date: 03-07-2028.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.Liner: mpact 01.32.3644hc10a face-changing 10° pe hc liner ø36/e (k183582) lot.2004539: (b)(4) items manufactured and released on 16-07-2020.Expiration date: 06-07-2025.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.Ball heads: cocr 01.25.034 cocr ball head 12/14 ø36 mm size xxl (k080885) lot.112523c: (b)(4) item manufactured and released on 10-01-2022.Expiration date: 14-12-2026.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Conclusions: 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.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 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: 22539992
• Report Number: 3005180920-2025-00700
• Device Sequence Number: 15436894
• Product Code: LZO
• UDI-Device Identifier: 07630030810794
• UDI-Public: 07630030810794
• 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): 07/18/2025

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: 01.32.152DH
• Device Lot Number: 2342592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• 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: 55 YR
• Patient Sex: Female