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

Catalog Number 01.32.3644HCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Joint Swelling (2356)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on (b)(6) 2017.Lot 170979: (b)(4) items manufactured and released on 06 june 2017.Expiration date: 2022-05-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Mectacer biolox delta ceramic ball head 12/14 ø 36 size m 0, code 01.29.209, lot.171413 (k112115).(b)(4) items manufactured and released on 25 july 2017.Expiration date: 2022-07-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of swollen and inflamed.The surgeon reviewed the patient and determined a revision was need.The surgeon washed and clean the area then changed the liner and head.

• Brand Name: MPACT FLAT PE HC LINER Ø36/E
• Type of Device: FLAT PE 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, 6874 ; SZ 6874
• MDR Report Key: 7013791
• MDR Text Key: 91495655
• Report Number: 3005180920-2017-00640
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• 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: Other
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Catalogue Number: 01.32.3644HCT
• Device Lot Number: 170979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2017
• 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