MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/F; HIP ACETABULAR LINER

Catalog Number 01.32.4048HCT

Device Problem Device Appears to Trigger Rejection (1524)

Event Date 03/29/2024

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 05 april 2024.Lot 2314080: (b)(4) items manufactured and released on 02-aug-2023.Expiration date: 2028-jul-10.No anomalies found related to the problem.To date, 93 items of the same lot have been sold with another similar reported event during the period of review.Additional component involved in the event: ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot 2346014: (b)(4) items manufactured and released on 20-dec-2023.Expiration date: 2028-11-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no other similar reported event during the period of review.

Event Description

The patient had a primary hip surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the head and liner.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/F
• Type of Device: HIP ACETABULAR 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: 19178925
• MDR Text Key: 341001552
• Report Number: 3005180920-2024-00266
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030812262
• UDI-Public: 07630030812262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122641
• 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: 04/25/2024

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: 01.32.4048HCT
• Device Lot Number: 2314080
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/02/2023
• 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: 71 YR
• Patient Sex: Male