MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SYSTEM; ACETABULAR SHELL Ø58 MULTI-HOLE

Model Number	01.32.158MH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Medical device site infection (4845); Septic loosening (4884)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03-07-2025.Cup: mpact 01.32.158mh acetabular shell ø58 multi-hole lot.2349362: (b)(4) items manufactured and released on 29-07-2024 expiration date: 2029-07-10.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 (infection and mobilization considered).Additional components involved in the event.Liner: mpact 01.32.3648hct mpact flat liner hc 36/f (k103721) lot.2406864: (b)(4) items manufactured and released on 07-05-2024 expiration date: 2029-04-18.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.Screws: mpact 01.43.0015 cancellous bone screw ø 6,5 l 15 (k200391) lot 2315733: (b)(4) items manufactured and released on 18-08-2023 expiration date: 2028-07-25.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.Screws: mpact 01.43.0020 cancellous bone screw ø 6,5 l 20 (k200391) lot.2312887: (b)(4) items manufactured and released on 12-07-2023 expiration date: 2028-06-26.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.Screws: mpact 01.43.0030 cancellous bone screw ø 6,5 l 30 200391) lot.2307613: (b)(4) items manufactured and released on 27-07-2023 expiration date: 2028-07-06.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.Screws: mpact 01.43.0020 cancellous bone screw ø 6,5 l 20 (k200391) lot.2319062: (b)(4) items manufactured and released on 06-09-2023 expiration date: 2028-08-21.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.Screws: mpact 01.43.0025 cancellous bone screw ø 6,5 l25(k200391) lot.2413325: (b)(4) items manufactured and released on 03-07-2024 expiration date: 2029-06-19.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.Screws: mpact 01.43.0035 cancellous bone screw ø 6,5 l35 (k200391) lot.2312906: (b)(4) items manufactured and released on 12-07-2023 expiration date: 2028-06-26.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: mectacer 01.29.208 mectacer head biolox delta dia.36 12/14-s (k132879) lot.2434502: (b)(4) items manufactured and released on 12-07-2023 expiration date: 2028-06-26.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 and septic mobilization are a known possible complication of primary hip arthroplasty.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.
Event or Problem Description
In (b)(6) 2025 the patient underwent tha.On the (b)(6), the patient underwent revision surgery due to an acetabular fracture caused by trauma.No mdr sent as it was a traumatic event.Currently, on the (b)(6), the patient underwent revision due to suspected infection.The surgeon removed the head and liner and performed a washout.Also, the surgeon tested the cup stability and found it mobilized.The surgeon then proceeded with the revision of the cup too with a 62 mpact two-holes cup.Surgery completed successfully.

• Brand Name: MPACT ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL Ø58 MULTI-HOLE
• 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: 22541818
• Report Number: 3005180920-2025-00629
• Device Sequence Number: 7013499
• Product Code: LZO
• UDI-Device Identifier: 07630030810909
• UDI-Public: 07630030810909
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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: 01.32.158MH
• Device Lot Number: 2349362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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: 81 YR
• Patient Sex: Female