MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM COLLARED HA COATED LAT STEM SIZE3; HIP STEM CEMENTLESS

Catalog Number 01.18.243

Device Problems Collapse (1099); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 21 november 2018: lot 125128: (b)(4) items manufactured and released on 17-jan-2013.Expiration date: 2017-12-31.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.Clinical evaluation performed by medical affairs director: 4 years after primary cementless tha, the stem subsided and was removed.The pre-revision radiographs show a stem that did not reach final seating, mostly because the femoral resection was very low, reaching the summit of the lesser trochanter.This was probably originated by either surgical or anatomical conditions that we cannot judge based on the information available.In this situation, we can conclude that the failure must not be attributed to a defective device.

Event Description

About 4 years after primary the surgeon revised the patient for stem subsidence.Stem, head and liner swap was performed.The surgery was completed successfully.The surgeon used an anterior approach for both the primary and revision surgeries.

• Brand Name: STEM COLLARED HA COATED LAT STEM SIZE3
• Type of Device: HIP STEM CEMENTLESS
• 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: 8095209
• MDR Text Key: 128061103
• Report Number: 3005180920-2018-00927
• Device Sequence Number: 0
• Product Code: LZO
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 01.18.243
• Device Lot Number: 125128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2013
• 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