MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48; DOUBLE MOBILITY CUP

Model Number	01.32.148MB
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 months after the primary, the patient came in reporting instability and the surgeon observed that the cup was anteverted.The surgeon revised the medacta cup and liner with competitor components and revised the medacta head with a medacta head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06 october 2022.Lot 2100559: (b)(4) items manufactured and released on 23-june-2021.Expiration date: 2026-05-19.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.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
• Common Device Name: DOUBLE MOBILITY 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15631723
• Report Number: 3005180920-2022-00788
• Device Sequence Number: 7970556
• Product Code: LPH
• UDI-Device Identifier: 07630030860959
• UDI-Public: 07630030860959
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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 Expiration Date: 05/19/2026
• Device Model Number: 01.32.148MB
• Device Catalogue Number: 01.32.148MB
• Device Lot Number: 2100559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• 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