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

Model Number	01.26.45.1150
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager.Looking at the image attached to the complaint it is visible that the explanted stem is covered with patient blood.It is possible to recognize some ha residuals on the stem body.Additionally some sings are present on the neck part probably due to revision surgery.The implant was revised following a low-grade infection, there is no indication that any issue with the devices may have caused or contributed to the event.Batch review performed on 05 april 2022.Lot 2006336: (b)(4) items manufactured and released on 16-sep-2020.Expiration date: 2025-09-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional components involved: ball heads: mectacer 01.29.208 biolox delta ceramic ball head 12/14 ø 36 size s - 4 (k112115) lot.2002606: (b)(4) items manufactured and released on 29-jul-2020.Expiration date: 2025-07-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Stem: quadra-h 01.12.23sn cementless, ha coated std stem # 3, short neck (k082792) lot.2007265: (b)(4) items manufactured and released on 30-sep-2020.Expiration date: 2025-09-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Liner: mectacer 01.29.413 ceramic liner ø 36 / e (not registered in usa) lot.2002628: (b)(4) items manufactured and released on 03-aug-2020.Expiration date: 2025-07-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.
Event or Problem Description
All implants were revised 1 year after primary following a low-grade infection.An antibiotic spacer has been implanted.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
• Common Device Name: ACETABULAR CUP CEMENTLESS
• 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: 14019807
• Report Number: 3005180920-2022-00228
• Device Sequence Number: 6056607
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122911
• 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): 04/06/2022

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: 09/07/2025
• Device Model Number: 01.26.45.1150
• Device Catalogue Number: 01.26.45.1150
• Device Lot Number: 2006336
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2020
• 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 Sex: Unknown