MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP 01.26.54MB ACETABULAR SHELL Ø 54; HIP ACETABULAR CUP

Model Number 01.26.54MB

Device Problem Osseointegration Problem (3003)

Patient Problem Implant Pain (4561)

Event Date 05/17/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 may 2023.Lot 110823: (b)(4) items manufactured and released on 27-may-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 during the period of review.Clinical evaluation: on (b)(6) 2023, 5 years and 7 months after revision tha surgery, the patient came in reporting pain.From the radiographic image, the position of the acetabular cup appears to be suboptimal.We cannot tell if this is the result of post-surgery migration or the surgeon's choice: in the latter case, no explanation for this decision was supplied.There is no reason to suspect a malfunctioning device.

Event Description

The patient had a primary hip surgery on (b)(6) 2011 on (b)(6) 2017, the patient came in complaining of a leg length discrepancy.The surgeon revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to loosened cup and the cause is unknown.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.

• Brand Name: CUP: VERSAFITCUP 01.26.54MB 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: 17142662
• MDR Text Key: 317303486
• Report Number: 3005180920-2023-00425
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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 Model Number: 01.26.54MB
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 110823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2011
• 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 Sex: Male