MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP, ACETABULAR SHELL CC TRIO Ø 62; ACETABULAR CEMENTLESS SHELL

Catalog Number 01.26.45.0062

Device Problems Loose or Intermittent Connection (1371); Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 the medical affairs director made the following evaluation: mobilization of cementless versafitcup less than two months after implantation.Unusual event, the cup tilted (presumably) and perforated the medial wall.There is no evidence on initial position of the cup or possible damage to the medial wall.Patient very tall and heavy.Reportedly, the stem was found loose proximally (short time after implantation, and with a tilted migrated cup no proper loading was possible).Investigations are ongoing for possible infection.At current state, the root cause cannot be identified with certainty.On (b)(6) 2016 it was communicated that the surgeon has not responded further regarding suspected reason for revision.The implants are not available for inspection due to hospital policy.Bone quality was average.Batch review performed on (b)(64) 2016.Lot 150081: 60 items manufactured and released on (b)(6) 2015.Expiration date: (b)(64) 2020.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any similar reported event.Quadra h cementless, ha coated lat stem # 7 code 01.12.037 lot.081295/t (b)(4).4 items manufactured and released on (b)(6) 2014.Expiration date: (b)(6) 2018.No anomalies found related to the problem.To date, 2 items of the same lot have been already sold without any similar reported event.

Event Description

Cup protruded through the acetabular medial wall.Discrepancy noticed on appearance of x-rays.The stem was also loose proximally which was noticed during surgery.

Manufacturer Narrative

On 02 april 2016 it was prepared a final report with the information already submitted in the initial report.On 11 april 2016 the report was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP, ACETABULAR SHELL CC TRIO Ø 62
• Type of Device: ACETABULAR CEMENTLESS 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, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5406867
• MDR Text Key: 37384233
• Report Number: 3005180920-2016-00012
• Device Sequence Number: 1
• Product Code: LZO
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2020
• Device Catalogue Number: 01.26.45.0062
• Device Lot Number: 150081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2015
• 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: 72 YR
• Patient Weight: 130