MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL 58

Model Number 01.26.58MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 23-jul-2020: lot 092437: (b)(4) items manufactured and released on 18-nov-2009.Expiration date: 31-oct-2014.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in reporting pain due to a migrated cup that arose from poor fixation 10 years and 3 months after the primary surgery.The surgeon revised the cup and head and the surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL 58
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10366569
• MDR Text Key: 201691835
• Report Number: 3005180920-2020-00502
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• 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: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2014
• Device Model Number: 01.26.58MB
• Device Catalogue Number: 01.26.58MB
• Device Lot Number: 092437
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2009
• 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