MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED STD STEM SIZE 00; CEMENTLESS STEM

Catalog Number	01.18.098
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 october 2019.Lot 131625: (b)(4) items manufactured and released on 2-aug-2013.Expiration date: 2018-06-30.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: 5 years after primary cementless tha in a very light elderly woman the stem gets loose.We have only the frontal xray that does not allow evaluation of potential under sizing of stem.As no other information is available, we cannot identify a definite root cause for this adverse event.
Event or Problem Description
Revision surgery performed 5 years after the primary surgery due to femoral loosening.

• Brand Name: STEM: AMISTEM H HA COATED STD STEM SIZE 00
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9206480
• Report Number: 3005180920-2019-00878
• Device Sequence Number: 305757
• Product Code: LZO
• UDI-Device Identifier: 07630030803765
• UDI-Public: 07630030803765
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2019

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: 06/30/2018
• Device Catalogue Number: 01.18.098
• Device Lot Number: 131625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/18/2019
• 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: 80 YR
• Patient Weight: 47