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

Model Number	01.26.2848MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023 lot 2103095: 120 items manufactured and released on (b)(6) 2021.Expiration date: 2026-04-13.No anomalies found related to the problem.To date, 113 items of the same lot have been sold without any similar reported event during the period of review.Additional item involved in the event, batch review performed on (b)(6) 2023: cup: mpact 01.32.148mb double mobility acetabular shell ø48 (k143453) lot.2102139 lot 2102139: 28 items manufactured and released on (b)(6) 2021.Expiration date: 2026-06-07.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with another similar reported event during the period of review.
Event or Problem Description
After medacta primary surgery performed on (b)(6) 2022 (previously the patient had competitor devices), on (b)(6) 2022 the patient came in reporting pain due to joint dislocation (dm liner from the dm cup) and the cause is unknown.The surgeon revised the cup, liner, head, and proximal body of the stem.The surgery was completed successfully.

• Brand Name: LINER: MPACT DOUBLE MOBILITY HC LINER 28/DMD
• Common Device Name: HIP DOUBLE MOBILITY LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16467864
• Report Number: 3005180920-2023-00130
• Device Sequence Number: 12078077
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/02/2023

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: 04/13/2026
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 2103095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2021
• 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