MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE2; CEMENTLESS STEM

Model Number	01.18.242
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 july 2018: lot 133015:30 items manufactured and released on 02 september 2013.Expiration date: 2018-07-31.No anomalies found related to the problem.To date, 26 items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs manager on jul 12, 2018: partial hip revision surgery (stem, head and liner) occurred 3 years and 6 months after primary cementless total hip arthroplasty.Radiographic images provided show the presence of radiolucent lines around the stem suggesting mobilization.Aseptic loosening is a possible, literature described adverse event after cementless hip arthroplasty and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
The patient came in complaining of pain 3 years and 6 months after primary.The surgeon determined that the stem had potted.The surgeon revised the stem, head and liner.The surgery was completed successfully.

• Brand Name: AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7718470
• Report Number: 3005180920-2018-00544
• Device Sequence Number: 11016816
• Product Code: LZO
• UDI-Device Identifier: 07630030804670
• UDI-Public: 07630030804670
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 07/31/2018
• Device Model Number: 01.18.242
• Device Lot Number: 133015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/25/2018
• 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