MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA AMISTEM H CEMENTLESS STEM #2 LAT; CEMENTLESS FEMORAL STEM MEH, LZO

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Batch review performed on (b)(6) 2015.Lot 146188: (b)(6) stems manufactured and released on (b)(6) 2015.No anomalies found related to the problem.To date, 18 items of the lot have been already sold without any similar issue reported.Preliminary analysis made by the responsible of the packaging department on (b)(6) 2015 based on a picture of the foreign matter: nothing can be said: dimensions and material not clear from the picture and we cannot know if it comes from our process.On (b)(6) the further analysis was made: we received an object similar to a residue of a burned plastic part.During investigation the responsible of packaging dept, reported: the operator during packaging steps did not detect any anomaly.He performed the controls required in the control instruction (visual inspection).The material received is not compatible with the materials available in clean room (included clothing), it is not possible determine the origin of the return material.The possible root cause of the event are: the object was not detected during the control by the operator; the object accidentally fell out in the packaging during the opening of the packaging.This kind of event is rare.

Manufacturer Narrative

On 24 july 2015 it was prepared a final report with the information collected during the investigation, already reported in the initial report.On the same day the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H CEMENTLESS STEM #2 LAT
• Type of Device: CEMENTLESS FEMORAL STEM MEH, LZO
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; strada regina; castel san pietro 6874 ; SZ 6874 ; 8782381
• MDR Report Key: 4782511
• MDR Text Key: 20442586
• Report Number: 3005180920-2015-00092
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Type of Report: Initial
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1