MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM HA COATED STD STEM SIZE 9; UNCEMENTED HIP STEM

Catalog Number	01.18.139
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 sep 2019: lot 177151: 47 items manufactured and released on 08-feb-2018.Expiration date: 31-jan-2023.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
Hip revision surgery due to non-osseointegration of the stem at the metaphysis level 9 months after primary surgery.

• Brand Name: STEM: AMISTEM HA COATED STD STEM SIZE 9
• Common Device Name: UNCEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9109068
• Report Number: 3005180920-2019-00792
• Device Sequence Number: 14101180
• Product Code: LZO
• UDI-Device Identifier: 07630030804151
• UDI-Public: 07630030804151
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• 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
• Report Date (Section B): 09/24/2019

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: 01/31/2023
• Device Catalogue Number: 01.18.139
• Device Lot Number: 177151
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2019
• Initial Report FDA Received Date: 09/24/2019
• 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: 56 YR
• Patient Weight: 102