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

Catalog Number 01.18.133

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

On 18 august 2017 the medical affairs director performed a clinical evaluation and commented as follows: partial hip revision surgery (stem and head) in a (b)(6) man occurred 5 years after primary cementless tha.In the single radiographic image provided, the stem looks well implanted.Reduced bone density can be seen in the trochanteric region.Aseptic loosening is a possible, literature described mid-term adverse event after tha and causes are often unknown.The reason of this failure cannot be determined.Batch review performed on 28 august 2017.Lot 113914: (b)(4) items manufactured and released on 12 january 2012.Expiration date: 2016-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.

Event Description

The patient complained of hip pain.Revision surgery has been performed due to suspicion of loosening.The stem came out easily.The surgery was completed successfully.

• Brand Name: AMISTEM H, 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
• MDR Report Key: 6829719
• MDR Text Key: 83961837
• Report Number: 3005180920-2017-00482
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/30/2017

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: 12/31/2016
• Device Catalogue Number: 01.18.133
• Device Lot Number: 113914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2012
• 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: 71 YR
• Patient Weight: 86