MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56; HIP ACETABULAR SHELL CC TRIO NO-HOLE

Model Number	01.26.45.1156
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 march 2023.Lot 2011634: (b)(4) items manufactured and released on 25-march-2021.Expiration date: 2026-02-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Preliminary investigation performed by r&d manager: from the received photos and information, it was not possible to determine a root cause of the event.Other device involved: stem: masterloc 01.39.204 cementless ti coated lat stem size 4 (k151531).
Event or Problem Description
Revision surgery performed due to infection.
Event or Problem Description
At about 1 year 5 months after the primary, revision surgery performed due to infection.The surgeon revised successfully all components.
Additional Manufacturer Narrative
Addiional components involved in the event: batch review performed on 21 march 2023.Liner: versafitcup cc trio 01.26.3648hct flat pe hc liner ø 36 / f (k103352) lot 2009643: (b)(4) items manufactured and released on 20-nov-2020.Expiration date: 2025-11-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.2011679: (b)(4) items manufactured and released on 25-march-2021.Expiration date: 2026-02-10.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Stem: masterloc 01.39.204 cementless ti coated lat stem size 4 (k151531) lot.2009556: (b)(4)items manufactured and released on 05-jan-2021.Expiration date: 2025-12-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56
• Common Device Name: HIP ACETABULAR SHELL CC TRIO NO-HOLE
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16553137
• Report Number: 3005180920-2023-00157
• Device Sequence Number: 2834609
• Product Code: LZO
• UDI-Device Identifier: 07630030807916
• UDI-Public: 07630030807916
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 02/18/2026
• Device Model Number: 01.26.45.1156
• Device Catalogue Number: 01.26.45.1156
• Device Lot Number: 2011634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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 Sex: Unknown