MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52; CEMENTLESS ACETABULAR SHELL

Catalog Number 01.26.45.0052

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 07 jun 2019: lot 164700: (b)(4) items manufactured and released on 16-nov-2016.Expiration date: 2021-11-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

About 1 year after primary surgery the surgeon revised the medacta total hip due to acetabulum implant malposition, approximatively 50° anteverted, which caused cup and stem to rub on each other and stem had worked loose.All implants revised successfully and competitor implants implanted.Primary surgery performed with amis technique.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
• Type of Device: CEMENTLESS 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: 8695353
• MDR Text Key: 147873286
• Report Number: 3005180920-2019-00458
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103352
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 164700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2016
• 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
• Patient Age: 54 YR
• Patient Weight: 75