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

Catalog Number 01.26.45.0050

Device Problem Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/12/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 332180330
• Report Number: 3005180920-2023-01070
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 2000131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White