MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50

Model Number 01.18.131

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 20-aug-2020.Lot 1909299: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 09.03.2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

After the primary hip surgery, the patient had post-op x-rays taken.The post-op x-rays indicated that the cup was loose.The surgeon revised the cup, liner, and head 1 day after the primary surgery.The surgery was completed successfully.

• Brand Name: CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874, sz; SZ
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 -CHE ; SZ 6874 CHE
• MDR Report Key: 10499472
• MDR Text Key: 205876103
• Report Number: 3005180920-2020-00582
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K143453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/07/2020

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: No Information
• Device Model Number: 01.18.131
• Device Catalogue Number: 01.32.150MB
• Device Lot Number: 1909299
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2020
• 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