MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50; HIP ACETABULA SHELL CEMENTLESS

Catalog Number	01.26.45.1150
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 july 2023: lot: 2008836: (b)(4) items manufactured and released on 18-nov-2020.Expiration date: 2025-11-04.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Additional involved implants: batch review performed on 18 july 2023 on liner: mectacer 01.29.410 ceramic liner ø 32 / e lot.2010646.Lot: 2010646: (b)(4) items manufactured and released on 17-feb-2021.Expiration date: 2026-02-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Item not registered in us.Batch review performed on 18 july 2023 on stem: amistem p 01.18.403 amistem-p std stem size 3 (k173794) lot.2010548.Lot: 2010548: (b)(4) items manufactured and released on 07-jan-2021.Expiration date: 2025-12-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Batch review performed on 18 july 2023 on ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot.2010628.Lot: 2010628: (b)(4) items manufactured and released on 10-feb-2021.Expiration date: 2026-01-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.
Event or Problem Description
Revision surgery at about 2 years from primary for hip infection.All devices revised successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Common Device Name: HIP ACETABULA SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17413517
• Report Number: 3005180920-2023-00596
• Device Sequence Number: 15697146
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 07/28/2023

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: 11/04/2025
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 2008836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2020
• 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: 52 YR
• Patient Sex: Male
• Patient Race: White