MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 54; HIP ACETABULAR CUP

Catalog Number 01.26.54MB

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 september 2023: lot 110790: 36 items manufactured and released on 01-jun-2011.Expiration date: 2016-04-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision for acetabulum bone fracture at about 12 years and 1 month post primary surgery.Versafitcup dm, liner and head revised successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 54
• Type of Device: HIP 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: 17904520
• MDR Text Key: 325279035
• Report Number: 3005180920-2023-00797
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 110790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2011
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White