MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT 3D METAL ACETABULAR SHELL Ø58 TWO-HOLE; HIP ACETABULAR CUP CEMENTLESS

Model Number	01.38.058DH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in for a post-op appointment 1 month after the primary surgery and it was observed that the acetabular cup moved and is in protrusion and the cause is unknown.The surgeon revised the cup, head, and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17-august-2022.Lot 2201526: (b)(4) items manufactured and released on 01-mar-2022.Expiration date: 2027-02-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: CUP: MPACT 3D METAL ACETABULAR SHELL Ø58 TWO-HOLE
• Common Device Name: HIP ACETABULAR CUP CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15247649
• Report Number: 3005180920-2022-00617
• Device Sequence Number: 12214462
• Product Code: LPH
• UDI-Device Identifier: 07630030812620
• UDI-Public: 07630030812620
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 08/18/2022

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 Model Number: 01.38.058DH
• Device Catalogue Number: 01.38.058DH
• Device Lot Number: 2201526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: Unknown