MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52

Model Number	01.26.45.0052
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 may 2021 lot 1811152: 320 items manufactured and released on 21-mar-2019.Expiration date: 2024-03-10.No anomalies found related to the problem.To date, 196 items of the same lot have been already sold without any other similar reported event.Clinical evalaution performed by medical affairs manager: acetabular component revision performed 2 years after primary cementless total hip arthroplasty in a (b)(6) year old woman.According to the report, the patient reported pain.No conclusion can be drawn from the single anteroposterior radiographic image provided.The reason of this event cannot be determined additional items involved in the event, batch review performed on 26 may 2021 ball heads: mectacer 01.29.205 biolox delta ceramic ball head 12/14 ø 32 size m 0 (k112115) lot.1810797 lot 1810797: 320 items manufactured and released on 11-mar-2019.Expiration date: 2024-02-24.No anomalies found related to the problem.To date, 317 items of the same lot have been already sold without any other similar reported event.Liner: mectacer 01.29.410 ceramic liner ø 32 / e lot.1810814 (the item is not registered in usa) lot 1810814: 227 items manufactured and released on 07-mar-2019.Expiration date: 2024-02-26.No anomalies found related to the problem.To date, 221 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Hip revision surgery performed on the right side following anterior pain only, no infection or implant loosening.Cup, liner and head have been successfully revised 1 year and 11 months after primary.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12023462
• Report Number: 3005180920-2021-00496
• Device Sequence Number: 4899144
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 03/10/2024
• Device Model Number: 01.26.45.0052
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 1811152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 86