MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLE; HIP CEMENTLESS ACETABULAR SHELL TWO-HOLES

Catalog Number	01.38.058DH
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 december 2023 lot 2216618: 38 items manufactured and released on 10-oct-2022.Expiration date: 2027-10-10.No anomalies found related to the problem.To date,(b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional involved implants batch review performed on 12 december 2023 on liner: mpact 01.32.4048hct flat pe hc liner ø40/f (k122641) lot.2302855 lot 2302855: (b)(4) items manufactured and released on 29-march-2023.Expiration date: 2028-03-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 12 december 2023 on ball heads: mectacer 01.29.213 biolox delta ceramic ball head 12/14 ø 40 size m 0 (k112115) lot.2314755 lot 2314755: (b)(4) items manufactured and released on 20-june-2023.Expiration date: 2028-05-30.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
At about 1 month after the primary, the patient came in due to signs of infection and the pathogen is unknown.While the surgeon was performing a washout, he observed the cup was loose due to infection.The surgeon revised the cup, liner and head and the surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø58 TWO-HOLE
• Common Device Name: HIP CEMENTLESS ACETABULAR SHELL 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: 18324593
• Report Number: 3005180920-2023-00996
• Device Sequence Number: 15293253
• Product Code: LPH
• UDI-Device Identifier: 07630030812620
• UDI-Public: 07630030812620
• 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: 2023
• Device Explanted Year: 2023
• 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): 12/14/2023

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: 01.38.058DH
• Device Lot Number: 2216618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2022
• 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