MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 62

Catalog Number 01.26.62MB

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23-oct-2019: lot 113446: 2 items manufactured and released on 28 september 2016. Expiration date: 2021-09-12. No anomalies found related to the problem. To date, all items of the same lot have been already sold without any similar reported event. Clinical evaluation performed by medical affairs department. Acetabular component revision performed 5 months after last revision surgery. An intraoperative fluoroscopic image was provided but it is not clear if it refers to the current revision or the previous one as no date is available. Information received concerning this event does not allow a proper clinical evaluation due to insufficient data. Additional device involved: liner: versafitcup dm 01. 26. 2862mhc double mobility hc liner 62/28 lot. 152697 (k092265) batch review performed on 23-oct-2019: lot 152697: 50 items manufactured and released on 03 august 2015. Expiration date: 2020-06-30. No anomalies found related to the problem. To date, 34 items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of pain 5 months after previous surgery, the cause of the pain was a torn tendon. The surgeon performed an abductor tendon repair and revised the cup and liner. The surgery was completed successfully. The patient had a first revision surgery in (b)(6) 2018 performed due to hip dislocation and a second revision in (b)(6) 2019.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 62
• Type of Device: ACETABULAR 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: 9224548
• MDR Text Key: 176280898
• Report Number: 3005180920-2019-00886
• Device Sequence Number: 1
• Product Code: MEH
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/12/2021
• Device Catalogue Number: 01.26.62MB
• Device Lot Number: 113446
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/23/2019 Patient Sequence Number: 1