MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F; HIP FLAT PE HC LINER

Catalog Number 01.32.3648HCT

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 12/10/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 december 2023: lot 2118355: (b)(4) manufactured and released on 01-feb-2022.Expiration date: 2027-01-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported event in the period of review.Other device involved: ball heads: mectacer 01.29.209 biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot 2336701: (b)(4) manufactured and released on 19-sep-2023.Expiration date: 2028-09-03.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event in the period of review.

Event Description

Revision surgery for suspected infection at about 1 month from primary.The head and liner have been revised successfully.

• Brand Name: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F
• Type of Device: HIP FLAT PE HC 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: 18474104
• MDR Text Key: 332421066
• Report Number: 3005180920-2023-01049
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103721
• 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: 01/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 2118355
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2023
• Initial Date FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• 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: 68 YR
• Patient Sex: Male