MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED STD STEM SIZE 2; CEMENTLESS HIP STEM

Catalog Number 01.18.232

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Joint Disorder (2373)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 13 april 2018: (b)(4).

Event Description

The patient came in complaining of pain 1 year and 3 months after the primary.The stem potted.The surgeon revised the stem and head with another company's product, the liner with a medacta liner.The surgery was completed successfully.

• Brand Name: STEM COLLARED HA COATED STD STEM SIZE 2
• Type of Device: CEMENTLESS HIP STEM
• 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: 7442496
• MDR Text Key: 105883577
• Report Number: 3005180920-2018-00245
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804571
• UDI-Public: 07630030804571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121011
• 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: 04/19/2018

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: 08/31/2021
• Device Catalogue Number: 01.18.232
• Device Lot Number: 163864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• 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