MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA AMISTEM H CEMENTLESS STEM #3 STD; CEMENTLESS FEMORAL STEM

Device Problems Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Batch review performed on (b)(6) 2015: lot 113277: (b)(4) stems manufactured and released on (b)(4) 2011.Expiration date: 2016-10-31.To date, all the stems of the lot have been sold without any similar reported issue.On (b)(6) 2015 the r&d dir checked a picture of the explanted item making the following comment: from the analysed pictures we can observe the explanted stem.Along the stem there are just few signs of osseointegration.The integrated areas are too small to consider this stem stable and well integrated.As expected there are no more ha along the stem body.On (b)(6) 2015 the med affairs dir made the following comment: osseointegration on the stem did not take place, but i cannot define the reason for this.It is an occurrence existing with tha.The pt seems to have some co-morbidities (from the x-ray, as no pt info is available) that may have contributed to lack of bone growth.

Manufacturer Narrative

On 28 august 2015 it was prepared a final report with the information already submitted in the initial report.On 31 august 2015 the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H CEMENTLESS STEM #3 STD
• Type of Device: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; strada regina 6874; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; strada regina 6874; castel san pietro ; SZ ; 8782381
• MDR Report Key: 4805651
• MDR Text Key: 19643909
• Report Number: 3005180920-2015-00105
• 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,other
• Type of Report: Initial
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1