MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 54/28; HIP DOUBLE MOBILITY LINER

Catalog Number	01.26.2854MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery the same day of primary for joint luxation (liner dm from shell).Shell, head and liner revised successfully.
Additional Manufacturer Narrative
Batch review performed on 10 september 2024: lot 2340535: (b)(4) items manufactured and released on 14-nov-2023.Expiration date: 2028-10-24.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.Clinical evaluation performed by medical affairs department: a revision surgery was performed immediately after the primary implantation of a total hip arthroplasty (tha) due to dislocation of the dm liner from the cup.The patient attempted to walk shortly after the surgery but reported a feeling of instability, prompting a follow-up x-ray that revealed the failure.The postoperative x-ray clearly shows dislocation between the cup and the mobile liner (radiolucent), as reported.Determining the reason for this failure is challenging.Given the timing, it is possible that the intraoperative reduction was only apparently complete, potentially due to the inner surface of the acetabular shell not being fully cleaned.It is less likely that the failure can be attributed to the positioning of the cup, as the revision surgery involved only modifications to the head and liner.With the information available, we cannot draw definitive conclusions.Additional implant involved: batch review performed on 10 september 2024 on cup: versafitcup 01.26.54mb acetabular shell ø 54 (k083116) lot.2307794 lot 2307794: (b)(4) items manufactured and released on 18-oct-2023.Expiration date: 2028-09-30.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 54/28
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20320863
• Report Number: 3005180920-2024-00783
• Device Sequence Number: 20809116
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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 Catalogue Number: 01.26.2854MHC
• Device Lot Number: 2340535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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 Age: 54 YR
• Patient Sex: Male