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 Fitting Problem (2183)

Patient Problem Failure of Implant (1924)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 12 september 2018.Lot 132994: (b)(4) items manufactured and released on 02 september 2013.Expiration date: 2018-07-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.

Event Description

About 4 years and a half after primary, the surgeon revised the patient for stem potting.Stem, head and liner swap performed 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, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7868587
• MDR Text Key: 119974953
• Report Number: 3005180920-2018-00670
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 01.18.232
• Device Lot Number: 132994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2013
• 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: 73 YR