MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H AMISTEM-H PROXIMAL COATING STD. SIZE 1; CEMENTLESS HIP STEM

Catalog Number 01.18.171

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 27 december 2018 lot 177114: (b)(4) items manufactured and released on 05 february 2018.Expiration date: 2023-01-25.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.Clinical evaluation performed by medical affairs director on december 18, 2018 early stem mobilization 9 months after cementless total hip arthroplasty in a (b)(6) man.Radiographic images provided show a proximally mobilized stem.No information concerning patient general health status or concomitant conditions that may have affected stem integration process is available.The patient is young and looks like a rather large and heavy man with a very narrow canal, a condition that is probably a challenge for any femoral stem, but we cannot ascribe to this situation such an early failure of the arthroplasty.On the basis of information received, the cause of this event cannot be determined.

Event Description

About 10 months after primary the surgeon will revise the patient for stem aseptic loosening.More info will be available after revision.Revision surgery planned on (b)(6) 2019.

Manufacturer Narrative

Additional information received after the revision: the stem was easily removed during surgery.Aseptic loosening confirmed.Revision completed successfully.

• Brand Name: AMISTEM H AMISTEM-H PROXIMAL COATING STD. SIZE 1
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8202417
• MDR Text Key: 131594033
• Report Number: 3005180920-2018-01044
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804366
• UDI-Public: 07630030804366
• Combination Product (y/n): N
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

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: 01/25/2023
• Device Catalogue Number: 01.18.171
• Device Lot Number: 177114
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR