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

Catalog Number 01.26.48MB

Device Problem Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs director: partial hip revision surgery (cup, head and liner) occurred 2 years and 4 months after cementless dual mobility total hip arthroplasty.According to the report the reason of pain could be soft tissue impingement but this cannot be confirmed on x-rays images.No other information useful for a clinical investigation has been supplied.Batch review performed on 27 february 2019: lot 160828: (b)(4) items manufactured and released on 25-may-2016.Expiration date: 2021-05-10.No anomalies found related to the problem.To date, all the items of this same lot have been already sold without any similar reported event.

Event Description

On january 31, 2019 we were informed about the fact that the surgeon was not pleased with the vertical placement of the cup and consequently would have revised the cup, head and liner on (b)(6) 2019.The revision was performed as planned and was completed successfully.According to the surgeon the pain was caused by the dm cup that was causing impingement of soft tissue.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Type of Device: CEMENTLESS HIP SHELL
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8374048
• MDR Text Key: 137271956
• Report Number: 3005180920-2019-00112
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2021
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 160828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2016
• 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