MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER 28/DMH; HIP SHELL DOUBLE MOBILITY LINER

Model Number 01.26.2856MHC

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 11/11/2021

Event Type  Injury  

Event Description

The patient came in 3 months after the primary surgery reporting pain due to a dislocation of the head from the liner.The surgeon revised the medacta stem and head with a medacta stem and head and revised the medacta cup and liner with a competitor cup and liner.The surgery was completed successfully.

Manufacturer Narrative

Batch review performed on 15 november 2021: lot 2005396: (b)(4) items manufactured and released on 07-sept-2020.Expiration date: 2025-08-27 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.Additional device involved.Batch review performed on 15 november 2021: ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot 2005396: (b)(4) items manufactured and released on 7-09-2020.Expiration date: 2025-08-27 no anomalies were found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported events.

• Brand Name: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH
• Type of Device: HIP SHELL DOUBLE MOBILITY 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: 12923715
• MDR Text Key: 281663162
• Report Number: 3005180920-2021-00960
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• 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: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 1910315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2020
• 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