MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 01.32.148MB DOUBLE MOBILITY ACETABULAR SHELL Ø 48; HIP DOUBLE MOBILITY ACETABULAR SHELL

Model Number	01.32.148MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 7 months after the primary surgery, the patient came in reporting pain due to a loose cup.The cause of the loose cup is unknown.The surgeon revised the head, liner, and cup with additional screws.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14-jul-2022: lot 2108085: (b)(4) items manufactured and released on 26-oct-2021.Expiration date: 2026-10-13.No anomalies found related to the problem.To date, 39 items of the same lot have been sold with no similar reported case during the period of the review.

• Brand Name: CUP: MPACT 01.32.148MB DOUBLE MOBILITY ACETABULAR SHELL Ø 48
• Common Device Name: HIP DOUBLE MOBILITY ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15174137
• Report Number: 3005180920-2022-00593
• Device Sequence Number: 6288740
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 08/05/2022

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: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2108085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2021
• 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