MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø56 TWO-HOLE; CEMENTLESS ACETABULAR CUP

Catalog Number	01.38.056DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 28-dec-2023.Lot 2201524:(b)(4) items manufactured and released on 28-feb-2022.Expiration date: 2027-02-15.No anomalies found related to the problem.To date, 38 items of the same lot have been sold with no similar reported case during the period of the review.Visual inspection performed by r&d project manager: during the analysis it is evaluated that, looking at the stem body an opaque white film is visible on the proximal part of the stem.It is not possible to identify if this film is ha or bone residual, or a combined effect.Non-absorption of ha from the stem body can indicate that metabolic activity wasn't taking place and that, presumably, not adequate bone contact was achieved at the time of surgery.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem failure reported.Additional implants involved in the event, batch review performed on 28-dec-2023.Stem: amistem-p collared 01.18.444 amistem-p collared lat stem size 4 (k173794) lot.1811135 lot 1811135: (b)(4) items manufactured and released on 08-apr-2019.Expiration date: 2024-03-23.No anomalies found related to the problem.To date, 13 items of the same lot have been sold with no similar reported case during the period of review liner: mpact 01.32.3648hct flat pe hc liner 36/f (k103721) lot.2114163.Lot 2114163: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-10.No anomalies found related to the problem.To date, 140 items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 36 size m 0 (k112115) lot.2115385 lot 2115385: (b)(4) items manufactured and released on 27-jan-2022.Expiration date: 2027-01-17.No anomalies found related to the problem.To date, 168 items of the same lot have been sold with no similar reported case during the period of the review.
Event or Problem Description
At about 1 year and 6 months after primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon explanted the cup, liner, head and stem and placed an antibiotic spacer per the 2 stage infection protocol.The surgery was completed successfully.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø56 TWO-HOLE
• Common Device Name: CEMENTLESS 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: 18510521
• Report Number: 3005180920-2023-01108
• Device Sequence Number: 6985010
• Product Code: LPH
• UDI-Device Identifier: 07630030812613
• UDI-Public: 07630030812613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 01/15/2024

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 Catalogue Number: 01.38.056DH
• Device Lot Number: 2201524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• 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