MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50; HIP ACETABULAR SHELL CC TRIO

Model Number	01.26.45.0050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 182557: 120 items manufactured and released on 26-jun-2018.Expiration date: 2026-03-13.No anomalies found related to the problem.To date, 116 items of the same lot have been sold without any similar reported event in the period of review.Other devices involved: batch review performed on (b)(6) 2022.Liner: versafitcup cc trio 01.26.3644hct flat pe hc liner ø 36 / e (k103352) lot 183106: 65 items manufactured and released on 14-aug-2018.Expiration date: 2023-07-19.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.Ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 183362: 200 items manufactured and released on 18-sept-2018.Expiration date: 2023-08-29.No anomalies found related to the problem.To date, 197 items of the same lot have been sold without any similar reported event in the period of review.
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.At about 4 years and 1 month post primary the surgeon revised the medacta cup and liner with a competitor's implants and revised the medacta head with a medacta head.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO 01.26.45.0050 ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: HIP ACETABULAR SHELL CC TRIO
• 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: 16021054
• Report Number: 3005180920-2022-00977
• Device Sequence Number: 5884088
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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: 03/13/2026
• Device Model Number: 01.26.45.0050
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 182557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2018
• 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: Female