MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52; HIP ACETABULAR CEMENTLESS SHELL

Catalog Number	01.26.45.0052
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During surgery, the hooded pe hc fixed liner ø 32 couldn't be clipped into the cup.The same problem happened with another hooded pe hc fixed liner ø 32 from a different lot.The surgeon decided to remove the cup and implanted a native cemented cup to complete the surgery.Delay time 30 minutes.
Additional Manufacturer Narrative
Batch review performed on 10 november 2023.Lot 2309931: 32 items manufactured and released on 18-jul-2023.Expiration date: 2028-07-02.No anomalies found related to the problem.To date, 21 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 10 november 2023.Liner: versafitcup cc trio 01.26.3244hcat hooded pe hc fixed liner ø 32 / e (k103352) lot 2311948: 88 items manufactured and released on 13-jul-2023.Expiration date: 2028-06-24.No anomalies found related to the problem.To date, 63 items of the same lot have been sold with no similar reported event during the period of review.Liner: versafitcup cc trio 01.26.3244hcat hooded pe hc fixed liner ø 32 / e (k103352) lot 2310226: 88 items manufactured and released on 08-aug-2023.Expiration date: 2028-07-22.No anomalies found related to the problem.To date, 55 items of the same lot have been sold with no similar reported event during the period of review.
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the liners and shell were tested in order to evaluate the compatibility: the insertion was performed correctly without signs of incompatibility.From the received pieces and information it is not possible to determine with certainty the root cause of the event, but it is possible that the presence of a liquid or other tissues was present in the shell during the impaction.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 52
• Common Device Name: HIP ACETABULAR 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: 18266624
• Report Number: 3005180920-2023-00931
• Device Sequence Number: 7891200
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 2309931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 72 KG