MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP ACETABULAR SHELL Ø 52

Model Number 01.26.52MB

Device Problem Naturally Worn (2988)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 24-feb-2020.Lot 083736: 46 items manufactured and released on 25-feb-2009.Expiration date: 31.01.2014.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, and the surgeon observed that the patient's posterior wall was worn away after about 11 years from the primary surgery.The surgeon replaced the posterior wall, added an augment and revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 52
• 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: 9744766
• MDR Text Key: 189010270
• Report Number: 3005180920-2020-00103
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: 01.26.52MB
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 083736
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2009
• 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
• Patient Age: 55 YR