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
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2021-00960
• Device Sequence Number: 11958948
• Product Code: MEH
• UDI-Device Identifier: 07630030807411
• UDI-Public: 07630030807411
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: 02/17/2025
• Device Model Number: 01.26.2856MHC
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 1910315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown