MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25; HIP CANCELLOUS BONE SCREW

Model Number	01.32.6525
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04-apr-2022: lot 2013778: (b)(4) items manufactured and released on 12-feb-2021.Expiration date: 2026-01-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in for a post-op appointment 8 months after the primary surgery reporting pain and x-rays showed a screw in the obturator foramen.The surgeon performed a right hip head and liner change with screw removal (two-holes cup).The surgery was completed successfully.

• Brand Name: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 25
• Common Device Name: HIP CANCELLOUS BONE SCREW
• 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: 14021289
• Report Number: 3005180920-2022-00242
• Device Sequence Number: 5938248
• Product Code: LPH
• UDI-Device Identifier: 07630030812385
• UDI-Public: 07630030812385
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• 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): 04/06/2022

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: 01/30/2026
• Device Model Number: 01.32.6525
• Device Catalogue Number: 01.32.6525
• Device Lot Number: 2013778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2021
• 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: Female