MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM IMPLANTS; FLAT PE HC LINER Ø32/D

Model Number	01.32.3241HCT
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 16 october 2025.Liner: mpact 01.32.3241hct flat pe hc liner ø32/d (k103721) lot2509643: (b)(4) items manufactured and released on04-jul-2025.Expiration date: 12-jun-2030.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 01.32.148dht acetabular shell ø48 two-holes t (k230011) lot2508415: (b)(4) items manufactured and released on09-jun-2025.Expiration date: 25-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 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.A possible reason could be related to the presence of liquid/tissue inside the shell or to an improper alignment of the two devices during the impaction.
Event or Problem Description
The liner could not be inserted into the cup.There was no lifting of the screws or the central plug.A new liner (from a different lot) was used, and the surgery was successfully completed.30 min delay to remove the liner and implant a new one (tot time 2 hours).

• Brand Name: MPACT ACETABULAR SYSTEM IMPLANTS
• Common Device Name: FLAT PE HC LINER Ø32/D
• 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: 23477195
• Report Number: 3005180920-2025-01058
• Device Sequence Number: 18698912
• Product Code: LPH
• UDI-Device Identifier: 07630030811876
• UDI-Public: 07630030811876
• Combination Product (Y/N): N
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.32.3241HCT
• Device Lot Number: 2509643
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/04/2025
• 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: Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian