MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H, HA COATED STEM SIZE 5 STD; CEMENTLESS FEMORAL STEM

Catalog Number 01.18.135

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

On 17 march 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial revision surgery of stem, head and double mobility liner in a young man (b)(6)) occurred 2 years after primary cementless tha.Radiographic image provided shows radiolucent lines in gruen zone 1 sign of proximal mobilization.Aseptic loosening is a possible, literature-described adverse event following tha and causes are often unknown.Batch review performed on 17 march 2017.Lot 145416: (b)(4) items manufactured and released on 11 october 2014.Expiration date: 2019-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Not available.

Event Description

The patient came in complaining of pain.The surgeon determined the 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 H, HA COATED STEM SIZE 5 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
• MDR Report Key: 6412990
• MDR Text Key: 70252306
• Report Number: 3005180920-2017-00117
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 01.18.135
• Device Lot Number: 145416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2014
• 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: 52 YR