MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø50 MULTI-HOLE; HIP ACETABULAR CUP CEMENTLESS

Model Number	01.32.150MH
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 4 months after the primary surgery, the patient came in for a post-op appointment and it was observed that the cup has mobilized.The cause of this is unknown.The surgeon revised successfully the cup, head, liner and screws.
Additional Manufacturer Narrative
Atch review performed on 29-jul-2022 lot 2006100: (b)(4) items manufactured and released on 10-nov-2020.Expiration date: 2025-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø50 MULTI-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: 15273675
• Report Number: 3005180920-2022-00645
• Device Sequence Number: 20392666
• Product Code: LPH
• UDI-Device Identifier: 07630030810770
• UDI-Public: 07630030810770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/23/2022

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: 01.32.150MH
• Device Catalogue Number: 01.32.150MH
• Device Lot Number: 2006100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2020
• 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