MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58; HIP CEMENTLESS SHELL

Catalog Number	01.26.45.0058
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 july 2023: lot 2248533: 32 items manufactured and released on 12-apr-2023.Expiration date: 2028-mar-25.No anomalies found related to the problem.To date, 18 items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved batch reviews performed on 19 july 2023: sms solid 01.36.052 sms solid stem std size 12 (k181693) lot 2204985: 10 items manufactured and released on 10-aug-2022.Expiration date: 2027-jul-27.No anomalies found related to the problem.To date, 4 items of the same lot have been sold with no similar reported event during the period of review.Mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2311347: 200 items manufactured and released on 31-may-2023.Expiration date: 2028-may-08.No anomalies found related to the problem.To date, 68 items of the same lot have been sold with no similar reported event during the period of review.Liner: mectacer 01.29.414 ceramic liner ø 36 / f (not marketed in us) lot 2310194: 90 items manufactured and released on 10-may-2023.Expiration date: 2028-apr-15.No anomalies found related to the problem.To date, 9 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
About 3 weeks after the primary surgery the implants were revised due to infection.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58
• Common Device Name: HIP CEMENTLESS SHELL
• 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: 17412886
• Report Number: 3005180920-2023-00604
• Device Sequence Number: 15239960
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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 Catalogue Number: 01.26.45.0058
• Device Lot Number: 2248533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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: 73 YR
• Patient Sex: Male