MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; CUP: MPACT 01.32.156DH ACETABULAR SHELL Ø56 TWO-HOLES

Model Number	01.32.156DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6)2024 the prosthesis was implanted in rosenklink.(b)(6)2024 implant-associated early infection with s.Epidermis.(external).(b)(6)2024 one-stage change of right hip tp from anterior, samples collected.(external).(b)(6)2024 explantation of total hip prosthesis right with implantation of spacer.(external).
Additional Manufacturer Narrative
Batch review performed on 10-01-2025.Lot 2345583: (b)(4) items manufactured and released on 22-05-2024.Expiration date: 2029-05-06.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.Other devices involved: liner: mpact 01.32.3248hct flat pe hc liner ø32/f (k103721) lot 2336926: (b)(4) items manufactured and released on 22-09-2023.Expiration date: 2028-09-10.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.Stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot 2403117: (b)(4) items manufactured and released on 24-04-2024.Expiration date: 2029-04-10.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 01.25.022 cocr ball head 12/14 ø 32 size m 0 (k072857) lot 2340526: (b)(4) items manufactured and released on 26-02-2024.Expiration date: 2029-02-08.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.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 01.32.156DH ACETABULAR SHELL Ø56 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: 21320607
• Report Number: 3005180920-2025-00019
• Device Sequence Number: 12794348
• Product Code: LZO
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/06/2025

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: 01.32.156DH
• Device Lot Number: 2345583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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: 82 YR
• Patient Sex: Male