MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; HIP ACETABULAR CUP

Model Number	01.32.150DHT
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 september 2024.Lot 2339116: 31 items manufactured and released on 27-feb-2024.Expiration date: 2029-02-13.No anomalies found related to the problem.To date, 21 items of the same lot have been sold without any similar reported event during the period of review.Additional devices involved in the event: batch review performed on 17 september 2024 other: screws 01.43.0025 cancellous bone screw ø 6,5 l 25 (k200391) lot 2348349: 46 items manufactured and released on 09-feb-2024.Expiration date: 2029-02-13.No anomalies found related to the problem.To date, 29 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 september 2024 stem: quadra-p 01.12.163 quadra-p collared std.Size 3 (k192827) lot 2339116: 28 items manufactured and released on 05-apr-2022.Expiration date: 2027-03-23.No anomalies found related to the problem.To date, 21 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 september 2024 ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot 2348075: 50 items manufactured and released on 09-jan-2024.Expiration date: 2028-12-16.No anomalies found related to the problem.To date, 39 items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 17 september 2024 liner: mpact 01.32.3644hcat hooded pe hc liner ø36/e (k132879) lot 2248469: 72 items manufactured and released on 10-feb-2023.Expiration date: 2028-01-23.No anomalies found related to the problem.To date, 66 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2024.Subsequently.The patient came in due to signs of infection and the pathogen was unknown.The surgeon performed a washout and revised the head and liner on (b)(6) 2024.Presently, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised the screw, cup, liner, head and stem.The surgery was completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: HIP ACETABULAR CUP
• 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: 20351567
• Report Number: 3005180920-2024-00801
• Device Sequence Number: 8024197
• Product Code: LPH
• UDI-Device Identifier: 07630345798749
• UDI-Public: 07630345798749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230011
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 01.32.150DHT
• Device Lot Number: 2339116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/02/2024
• 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 Sex: Female