MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28; HIP DOUBLE MOBILITY HIGHCROSS LINER

Catalog Number	01.26.2848MHC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain and the cause is unknown.About 3 years and 11 months after the primary surgery, the surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 august 2024.Lot 2003319: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-jun-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implant revised.Batch review performed on 20 august 2024 on ball heads: mectacer 01.29.202 biolox delta ceramic ball head 12/14 ø 28 size m 0 (k112115) lot.1907336.Lot 1907336: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-dec-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 48/28
• Common Device Name: HIP DOUBLE MOBILITY HIGHCROSS 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20180525
• Report Number: 3005180920-2024-00718
• Device Sequence Number: 15528463
• 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: 2020
• Device Explanted Year: 2024
• 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): 09/10/2024

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: 06/25/2025
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 2003319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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: Female