MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

Model Number 01.26.2850MHC

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 11/12/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18 november 2021.Lot 2101757: (b)(4) items manufactured and released on 06-may-2021.Expiration date: 2026-04-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional item involved in the event, batch review performed on 18 november 2021: cup: mpact 01.32.150mb double mobility acetabular shell ø50 (k143453) lot.2011702.Lot 2011702: (b)(4) items manufactured and released on 19-april-2021.Expiration date: 2026-03-29.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 Description

At 7 years 5 months the patient came in reporting pain due to a loose tibia.It was also observed that the screw had backed out of the poly.The reason for the loose tibia and the loose screw is unknown.The surgeon revised the femur, tibia, and insert.The surgery was completed successfully.

• Brand Name: LINER: MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28
• Type of Device: DOUBLE MOBILITY HC LINER
• 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: 12932364
• MDR Text Key: 281734523
• Report Number: 3005180920-2021-00962
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2850MHC
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2101757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2021
• 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