MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4; CEMENTLESS COLLARED STEM

Model Number	01.18.234
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2021.Lot 160108: (b)(4) items manufactured and released on 02-may-2016.Expiration date: 2021-04-20.No anomalies found related to the problem.To date, all items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.
Event or Problem Description
Revision surgery performed 4 years 6 months after the primary surgery due to stem mobilization.The surgeon revised the stem, head, and liner.

• Brand Name: STEM: AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 4
• Common Device Name: CEMENTLESS COLLARED STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11737285
• Report Number: 3005180920-2021-00332
• Device Sequence Number: 4167621
• Product Code: LZO
• UDI-Device Identifier: 07630030804595
• UDI-Public: 07630030804595
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 04/20/2021
• Device Model Number: 01.18.234
• Device Catalogue Number: 01.18.234
• Device Lot Number: 160108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/28/2021
• 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