MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H CEMENTLESS STEM SIZE 5 LAT; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.145

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Damage (2104)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

On 03 dec 2015 we received the confirmation that the revision was successfully performed on 02 dec 2015 and that the explants will not be available.Batch review performed on 21 december 2015: lot 104362: (b)(4) items manufactured and released on 10 february 2011.Expiration date: 2016-01-31.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.

Event Description

Due to a chronic and serious episode of osteoporosis, the stem presented a ditch and it was decided to remove the stem.Revision planned for (b)(6) 2015.

Manufacturer Narrative

X-rays received on 30 december 2015.On 01 january 2016, the medical affairs performed a clinical evaluation and commented as follows: aseptic loosening at 3 years in a patient with osteoporotic bone.The stem caused a very evident cortical thickening in gruen zones 3 and 5, but got loose in zones 1 and 7.Replacement with a cemented longer stem.Mobilization of a cementless stem is a known possible complication of tha; osteoporosis is a relative contraindication, meaning that the probability of mobilization in osteoporotic patients is statistically higher.Root cause for revision is aseptic loosening; cause for the latter is unknown, osteoporosis constitutes an objective difficult condition.

Manufacturer Narrative

On 29 january 2016 it was prepared a final report with the information already submitted in the previous reports.On the same date, the report was sent to the initial reporter and the case was closed.

• Brand Name: AMISTEM H CEMENTLESS STEM SIZE 5 LAT
• Type of Device: CEMENTLESS FEMORAL 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: 5318725
• MDR Text Key: 34132753
• Report Number: 3005180920-2015-00348
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 01.18.145
• Device Lot Number: 104362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2011
• 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: 75 YR
• Patient Weight: 78