MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ACETABULAR SHELL CC TRIO Ø 50; ACETABULAR CUP

Catalog Number	01.26.45.0050
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 january 2024.Lot 2000131: 200 items manufactured and released on 26-may-2020.Expiration date: 2025-may-14.No anomalies found related to the problem.To date, 199 items of the same lot have been sold with one similar reported event during the period of review.
Event or Problem Description
The patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.About 2 years and 9 months after the primary surgery, the surgeon revised the cup and liner with a competitor cup and liner and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: 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: 18451682
• Report Number: 3005180920-2023-01070
• Device Sequence Number: 15398951
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/05/2024

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: 05/14/2025
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 2000131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2020
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White