MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48; HIP UNCEMENTED SHELL

Model Number	01.26.45.0048
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 21 january 2022: lot 2007401: (b)(4) items manufactured and released on 16-nov-2020.Expiration date: 2025-oct-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional devices involved batch reviews performed on 21 january 2022: stem: quadra-h 01.12.20sn cementless, ha coated std stem size 0, short neck (k082792) lot 2000291: (b)(4) items manufactured and released on 28-may-2020.Expiration date: 2025-may-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Ball heads: mectacer 01.29.204 biolox delta ceramic ball head 12/14 ø 32 size s -4 (k112115) lot 2007625: (b)(4) items manufactured and released on 05-nov-2020.Expiration date: 2025-oct-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Ceramic liner was explanted, the device is not marketed in the usa.
Event or Problem Description
Revision surgery performed due to infection 10 months after the primary surgery.All implants removed and revised with competitor implants.

• Brand Name: VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48
• Common Device Name: HIP UNCEMENTED 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: 13505691
• Report Number: 3005180920-2022-00111
• Device Sequence Number: 11858345
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 02/10/2022

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: 10/29/2025
• Device Model Number: 01.26.45.0048
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 2007401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2020
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White