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

Model Number 01.26.62MB

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 february 2021: lot 081319: (b)(4) items manufactured and released on 14-oct-2008. Expiration date: 2013-08-31. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold. No other similar events have been reported since 2017. Clinical evaluation performed by medical affairs director: revision surgery performed 11 years after primary double-mobility total hip arthroplasty. No information concerning patient general health status is available. Radiographic images provided show suboptimal cup position: this may be the result of inadequate implant position during surgery or subsequent mobilization but this cannot be assessed not having immediate postoperative images; however, secondary cup migration is highly probable. The reason of this event cannot be determined, but there is no reason to suspect a faulty device.

Event Description

The patient came in reporting pain due to malpositioning of the cup. The cause of the malpositioned cup is unknown. The surgeon revised all the components with competitor hardware 10 years 11 months after the primary. The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 62
• Type of Device: ACETABULAR CUP
• 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: 11371451
• MDR Text Key: 233251687
• Report Number: 3005180920-2021-00139
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2013
• Device Model Number: 01.26.62MB
• Device Catalogue Number: 01.26.62MB
• Device Lot Number: 081319
• 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: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2008
• 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: 02/24/2021 Patient Sequence Number: 1