MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY SHELLS; HIP CEMENTLESS SHELL

Model Number	01.32.152MB
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain.Upon exploration, the surgeon observed poor cup placement.About 3 years and 2 months after the primary surgery, the surgeon revised the cup, liner and head.Cup was well fixed, it was probably malpositioned during primary, but this cannot be confirmed.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 october 2024: lot 2009457: (b)(4) items manufactured and released on 11-mar-2021.Expiration date: 2026-feb-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient came in reporting pain.Upon exploration, the surgeon observed poor cup placement.About 3 years and 2 months after the primary surgery, the surgeon revised the cup and liner with competitor components and head with medacta head.Cup was well fixed, it was probably malpositioned during primary, but this cannot be confirmed.The surgery was completed successfully.On (b)(6) 2024, the patient was revised again due to competitor's cup malpositioning (malpositioned cup causing impingement on the trunnion), and the medacta head was revised as per standard procedure.
Additional Manufacturer Narrative
On (b)(6) 2024 fwe have received the date of birth of the patient.On (b)(6) 2024, it was confirmed also that the cup implanted during the first revision was from competitor and that the patient was revised again on (b)(6) 2024 due to competitor cup impingement.Details added in the follow-up: patient date of birth: (b)(6) 1962.Event description.

• Brand Name: MPACT DOUBLE MOBILITY SHELLS
• Common Device Name: HIP CEMENTLESS SHELL
• 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: 20522022
• Report Number: 3005180920-2024-00868
• Device Sequence Number: 18403128
• Product Code: LZO
• UDI-Device Identifier: 07630030860973
• UDI-Public: 07630030860973
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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 Expiration Date: 02/28/2026
• Device Model Number: 01.32.152MB
• Device Lot Number: 2009457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown