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

Catalog Number	01.18.171
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8202417
• Report Number: 3005180920-2018-01044
• Device Sequence Number: 10815813
• Product Code: LZO
• UDI-Device Identifier: 07630030804366
• UDI-Public: 07630030804366
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2023
• Device Catalogue Number: 01.18.171
• Device Lot Number: 177114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR