MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52; ACETABUAL SHELL CEMENTLESS

Catalog Number	01.26.45.1152
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 may 2019 lot 188638: (b)(4) items manufactured and released on 06-feb-2019.Expiration date: 2024-01-24.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.Instrument involved in the issue: versafitcup general 01.26.10.0062 versafitcup cc cup impactor, lot 1753222: (b)(4) items manufactured and released on 22-feb-2018.No anomalies found related to the problem.To date, no similar event has been reported.Visual inspection performed by r&d (b)(4): the handle was stuck in the cup, it was necessary to block the cup in a clamp to disassembly the pieces.It might be possible that micro-deformations of the threads (cup and handle) caused by an improper use of the instrument (e.G.Cup repositioning) blocked the cup, but it could not be confirmed.
Event or Problem Description
After impacting the cup, the surgeon could not remove the straight cup impactor.He had to take the implant out and to use back-up cup with a back-up instrument.The surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO NO-HOLE Ø 52
• Common Device Name: ACETABUAL SHELL CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8607924
• Report Number: 3005180920-2019-00366
• Device Sequence Number: 2221332
• Product Code: LZO
• UDI-Device Identifier: 07630030807893
• UDI-Public: 07630030807893
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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 Expiration Date: 01/24/2024
• Device Catalogue Number: 01.26.45.1152
• Device Lot Number: 188638
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: Other