MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number 01.38.054DH

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Inadequate Osseointegration (2646)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 01 july 2019: lot 1810871: (b)(4) items manufactured and released on 17-jan-2019.Expiration date: 2024-01-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

7 days after primary the surgeon revised the patient hip for a loose shell.Cup, liner and screw revised successfully.

• Brand Name: CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
• Type of Device: HIP ACETABULAR SHELL
• 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: 8789417
• MDR Text Key: 150992943
• Report Number: 3005180920-2019-00584
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812606
• UDI-Public: 07630030812606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: 01.38.054DH
• Device Lot Number: 1810871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention