MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50

Model Number 01.26.45.1150

Device Problem Output Problem (3005)

Patient Problem Granuloma (1876)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18.11.2021: lot 135286: (b)(4).Expiration date: 2018-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event since 2017.Clinical evaluation performed by medical affairs director: hip revision surgery performed 7 years and 8 months after cementless total hip arthroplasty in a (b)(6) man.According to the report, the cause of implant mobilization is the presence of a granuloma.Radiographic images provided show bone alterations consistent with the presence of a mass.The cause of granuloma is unknown.Other devices involved: batch review performed on 18.11.2021: quadra-h 01.12.022 cementless, ha coated std stem size 2 (k082792) lot 135659: (b)(4).Expiration date: 2018-11-30.No anomalies found related to the problem.(b)(4).

Event Description

At 7 years 8 months, the surgeon revised all implants due to mobilization of the stem and shell caused by granuloma.The cause of granuloma is unknown.

• Brand Name: VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• 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: 12950769
• MDR Text Key: 282067580
• Report Number: 3005180920-2021-00952
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K122911
• 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: 12/07/2021

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: 11/30/2018
• Device Model Number: 01.26.45.1150
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 135286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2013
• 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: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White