MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø54 TWO-HOLES T

Model Number	01.32.154DHT
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months from the primary, the patient came in presenting pain due to a loose cup and it was determined that there was no bone growth on the implant which was the cause.The surgeon revised the d 54 shell to a d 62 multi-hole shell, the 36mm biolox head s to a 36mm biolox xl.And the d 36/f liner to a d 36/g liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 9 january 2026.Cup: mpact 01.32.154dht acetabular shell d 54 two-holes t (k230011) lot 2511723: (b)(4) items manufactured and released on 21-jul-2025.Expiration date: 06-jul-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:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø54 TWO-HOLES T
• 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: 24162759
• Report Number: 3005180920-2026-00042
• Device Sequence Number: 9252149
• Product Code: LPH
• UDI-Device Identifier: 07630345798763
• UDI-Public: 07630345798763
• Combination Product (Y/N): N
• PMA/510(K) Number: K230011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 01/23/2026

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: 01.32.154DHT
• Device Lot Number: 2511723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2025
• 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 Sex: Male