MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES; ACETABULAR CUP CEMENTLESS

Model Number	01.32.156DH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2022.Lot 2012944: (b)(4) items manufactured and released on 30-march-2021.Expiration date: 2026-mar-17.No anomalies found related to the problem.To date, no other items of the same lot have been sold.
Event or Problem Description
At 3 months after the primary, the patient came in reporting pain due to a loose cup and the cause of the loose cup is unknown.The surgeon revised the cup, head, and liner.The surgery was completed successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø56 TWO-HOLES
• Common Device Name: 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: 13469120
• Report Number: 3005180920-2022-00069
• Device Sequence Number: 5233331
• Product Code: LPH
• UDI-Device Identifier: 07630030810855
• UDI-Public: 07630030810855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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 Expiration Date: 03/17/2026
• Device Model Number: 01.32.156DH
• Device Catalogue Number: 01.32.156DH
• Device Lot Number: 2012944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• 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