MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 1 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.131

Device Problem Component Missing (2306)

Patient Problem Pain (1994)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 16 january 2017.Lot 136179: (b)(4).Items manufactured and released on 21 february 2014.Expiration date: 2019-01-31.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.On 17 january 2017 the r&d project manager performed a visual inspection of the retrieved stem and commented as follows: the piece was analyzed.Some signs of removal were present on the neck and on the taper.A fibrotic tissue was present on all the walls except in the proximal part.The ha coating was also present in some areas.From the received piece it is not possible to determine the root cause of the event.

Event Description

Amistem-h revision due to pain 1 year after primary; during revision it was noticed that the ha coating was not present anymore on some parts of the stem.

• Brand Name: AMISTEM H, HA COATED STEM SIZE 1 STD
• 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: 6260066
• MDR Text Key: 65059462
• Report Number: 3005180920-2016-00746
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 01.18.131
• Device Lot Number: 136179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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: 67 YR
• Patient Weight: 98