MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL 46 TWO-HOLES; CEMENTLESS ACETABULAR CUP

Model Number	01.32.146DH
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 4 may 2021: lot 2000222: (b)(4) items manufactured and released on 5- may-2020.Expiration date: 2025-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar events.Clinical evaluation performed by medical affairs director: intraoperative migration of acetabular cup during primary tha.For unspecified reasons, sufficient primary stability could not be achieved.There is no clinical cause for this adverse event.Preliminayr investigation performed by r&d project manager: from the received information, photo and x-rays it is not possible to determine a route cause of the event, probably related to an incorrect press-fit provided to the cup.Due to the thin dimensions of the rim of the liner, the removal of it was probably difficult during the surgery; no other conclusion can be done.After the receipt of the pieces, a further analysis of the coating can be performed.
Event or Problem Description
The surgeon noticed that the cup migrated from the patient acetabular after the final repositioning during the surgery.The surgeon replaced it with a new mpact multihole cup and liner.The was 1 hour surgery time delay.Total surgery time: 4 hours.The same size was used finally.It is unknown if additional anesthesia was necessary.
Additional Manufacturer Narrative
Visual inspection performed r&d manager: from the received pieces, it is confirmed what stated in the preliminary investigation; no particular or evident signs were noticed on the shell, so the event can be probably related an incorrect press-fit due to the patient bone conditions.

• Brand Name: CUP: MPACT ACETABULAR SHELL 46 TWO-HOLES
• Common Device Name: CEMENTLESS ACETABULAR CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11862214
• Report Number: 3005180920-2021-00409
• Device Sequence Number: 3663505
• Product Code: LPH
• UDI-Device Identifier: 07630030810701
• UDI-Public: 07630030810701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• 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): 06/25/2021

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: 04/22/2025
• Device Model Number: 01.32.146DH
• Device Catalogue Number: 01.32.146DH
• Device Lot Number: 2000222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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: Other
• Patient Age: 59 YR