MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40

Catalog Number	01.32.6540
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 october 2019.Lot 175083: 100 items manufactured and released on 20-sept-2017.Expiration date: 2022-09-08.No anomalies found related to the problem.To date, 32 items of the same lot have been already sold without any similar reported event.Additional implant involved in the event, batch review performed on 01 october 2019 screws: impact 01.32.6540 cancellous bone screw, flat head ø 6,5 l 40 (k103721) lot.168800 lot 168800: 130 items manufactured and released on 15-feb-2017.Expiration date: 2022-02-02.No anomalies found related to the problem.To date, 86 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.Post-op x-rays were taken and it was observed that the patient had internal bleeding.On (b)(6) 2019, the surgeon removed 2 impact dome screw 40mm screws and revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
On 24-october-2019 the following analysis was performed clinical evaluation performed by medical affairs director 1 year 3 months after cementless tha the cup is revised.The cause is probably the position of the screws used to stabilize the cup during index operation: the position and length of the ventral screws required attention.This problem was not caused by a malfunctioning device.

• Brand Name: SCREWS: MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40
• Common Device Name: CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9208358
• Report Number: 3005180920-2019-00880
• Device Sequence Number: 448871
• Product Code: LPH
• UDI-Device Identifier: 07630030812415
• UDI-Public: 07630030812415
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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: 09/08/2022
• Device Catalogue Number: 01.32.6540
• Device Lot Number: 175083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: Required Intervention