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
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3005180920-2021-00952
• Device Sequence Number: 4625758
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White