MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS STEM SIZE 2 STD; FEMORAL CEMENTLESS STEM

Catalog Number 01.18.132

Device Problem Device Slipped (1584)

Patient Problem Unspecified Infection (1930)

Event Date 09/26/2015

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 october 2015: lot 134165: (b)(4) items manufactured and released on 30 october 2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported issue.Cocr ball head 12/14 ø 28 size l +3.5 code 01.25.013 lot.080587/t (k072857): lot 080587/t: (b)(4) items manufactured and released on 30 october 2013.Expiration date: 2018-09-30.No anomalies found related to the problem.To date, all the items of the same lot have been already sold without any similar reported issue.On october 09th 2015 we were informed that the pathogen is nocardia species.

Event Description

On (b)(6) 2014 patient had primary hip surgery.On (b)(6) 2015 (mdr 2015-00212) patient had revision of the ball head, liner and acetabular cup due to loosening.The surgeon used a medacta ball head with a non medacta liner and acetabular cup.On (b)(6) 2015 the medacta ball head and stem were removed along with the cup and liner.Antibiotic spacers were implanted due to infection.Patient requested to keep product so explants will not be available.

Manufacturer Narrative

On 28 dec 2015 it was prepared a final report with the information already submitted in the initial report.On 29 dec 2015 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H CEMENTLESS STEM SIZE 2 STD
• Type of Device: FEMORAL CEMENTLESS 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 ; 91 6966060
• MDR Report Key: 5188463
• MDR Text Key: 29861793
• Report Number: 3005180920-2015-00253
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 01.18.132
• Device Lot Number: 134165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2013
• 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: 64 YR