MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28; ACETABULAR LINER DOUBLE MOBILITY

Catalog Number 01.26.2850MHC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 30-aug-2023 lot 2302831: (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 2028-03-22.No anomalies found related to the problem.To date, 52 items of the same lot have been sold with no similar reported event during the period of review.Additional component involved: cup: mpact 01.32.150mb double mobility acetabular shell ø50 (k143453) lot.2247253: 32 items manufactured and released on 31-may-2023.Expiration date: 2028-05-16.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.

Event Description

On the same day of the primary, the patient sustained a joint dislocation.The surgeon performed surgery on the patient again and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT DOUBLE MOBILITY HC LINER Ø 50/28
• Type of Device: ACETABULAR LINER DOUBLE MOBILITY
• 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: 17649308
• MDR Text Key: 322250721
• Report Number: 3005180920-2023-00652
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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: 2302831
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2023
• 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: 56 YR
• Patient Sex: Female