MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC ACETABULAR SHELL CC 48; HIP CEMENTLESS SHELL

Model Number 01.26.48MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 july 2021: lot 2006310: (b)(4) items manufactured and released on 2-dec-2020.Expiration date: 23-11-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any reported event.

Event Description

2 months and a half after the primary surgery the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup, liner, and head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP CC ACETABULAR SHELL CC 48
• Type of Device: HIP CEMENTLESS SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12179428
• MDR Text Key: 261890768
• Report Number: 3005180920-2021-00611
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.48MB
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 2006310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2020
• 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