MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H HA COATED LAT SIZE 4; FEMORAL CEMENTLESS STEM

Model Number	01.18.144
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 april 2021: lot 160758: 44 items manufactured and released on 20-may-2016.Expiration date: 2021-05-03.No anomalies found related to the problem.To date, 36 items of the same lot have been already sold without any other similar reported event since 2017.
Event or Problem Description
The patient came in reporting pain.Post-op x-rays indicated that aseptic loosening of the stem had occurred.The surgeon revised the stem, head, and liner 4 years and 5 months after primary.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM H HA COATED LAT SIZE 4
• Common Device Name: FEMORAL CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11847283
• Report Number: 3005180920-2021-00386
• Device Sequence Number: 16949923
• Product Code: LZO
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• 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: 2016
• Device Explanted Year: 2021
• 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): 05/19/2021

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: 05/03/2021
• Device Model Number: 01.18.144
• Device Catalogue Number: 01.18.144
• Device Lot Number: 160758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/19/2021
• 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