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

Catalog Number 01.32.3648HCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 03-jan-2020.Lot 19001468: (b)(4) items manufactured and released on 25-apr-2019.Expiration date: 13.04.2024.No anomalies found related to the problem.To date, 107 items of the same lot have been already sold without any other similar reported event.Additional implant involved: ball heads: mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0 (k112115) lot.1903000.Batch review performed on 03-jan-2020.Lot 1903000: (b)(4) items manufactured and released on 12-jul-2019.Expiration date: 02.07.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in complaining of pain due to an oozing and breaking wound that is not healing correctly 1 month after primary.The surgeon performed an i&d and revised the head and liner.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø36/F
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9557479
• MDR Text Key: 175251518
• Report Number: 3005180920-2019-01133
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812132
• UDI-Public: 07630030812132
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/07/2020

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 Expiration Date: 04/13/2024
• Device Catalogue Number: 01.32.3648HCT
• Device Lot Number: 1901468
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2019
• 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