MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28; HIP LINER

Catalog Number 01.26.2850MHC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 06-sep-2023.Lot 2236018: 55 items manufactured and released on 18-oct-2022.Expiration date: 2027-09-29.No anomalies found related to the problem.To date, 48 items of the same lot have been sold with no similar reported case during the period of review.Additional implant involved, batch review performed on 06-sep-2023.Cup: mpact 01.32.156mh acetabular shell ø56 multi-hole (k132879) lot 2213428: 32 items manufactured and released on 05-oct-2022.Expiration date: 2027-09-25.No anomalies found related to the problem.To date, 10 items of the same lot have been sold with no similar reported case during the period of review.

Event Description

The patient had a primary hip surgery on (b)(6) 2023.Soon after the primary hip surgery, the patient sustained a dislocation of the head from the liner.The surgeon revised all implants successfully.Presently, on (b)(6) 2023, the patient came in reporting pain due to joint luxation (dislocation of the head and liner from the cup) and the cause is unknown.The surgeon revised the head and liner successfully.

• Brand Name: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
• Type of Device: HIP 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: 17690081
• MDR Text Key: 322723960
• Report Number: 3005180920-2023-00689
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807282
• UDI-Public: 07630030807282
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.2850MHC
• Device Lot Number: 2236018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2022
• 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
• Patient Age: 69 YR
• Patient Sex: Male