MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM HA COATED STEM SIZE 3 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.233

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 08/30/2016

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2016 the (b)(6) performed a clinical evaluation and commented as follows: proximal loosening in a cementless tha 1.5 years old.Only an intra-operative fluoroscopy shot is available, hence no real analysis is possible.No apparent reason for this stem to get loose could be identified on the image or the report.The cause for this problem remains unknown to date.Batch review performed on 23 september 2016.Lot 147177: (b)(4) items manufactured and released on 21 january 2015.Expiration date: 2019-12-31.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

The patient came in complaining of pain.The proximal stem was loose.The surgeon revised the stem, head and liner.The surgery was completed successfully.X-rays are available.Explants are not available.

• Brand Name: AMISTEM COLLARED STEM HA COATED STEM SIZE 3 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: 5987047
• MDR Text Key: 55926373
• Report Number: 3005180920-2016-00495
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K121011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 01.18.233
• Device Lot Number: 147177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2015
• 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: 60 YR