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

Model Number	01.18.143
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 january 2021: lot 150141: (b)(4) items manufactured and released on 28-apr-2015.Expiration date: 2020-03-31.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 since 1-1-2017.
Event or Problem Description
Revision surgery was performed due to potted stem 5 yeas and 2 months after primary.The surgery was completed successfully.Stem, head and liner were revised.

• Brand Name: STEM: AMISTEM HA COATED LAT STEM SIZE 3
• Common Device Name: FEMORAL STEM HA COATED CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11236074
• Report Number: 3005180920-2021-00070
• Device Sequence Number: 14510176
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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: 03/31/2020
• Device Model Number: 01.18.143
• Device Catalogue Number: 01.18.143
• Device Lot Number: 150141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/27/2021
• 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