MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0; HIP STEM

Model Number	01.18.130
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 november 2020: lot 133052: (b)(4) items manufactured and released on 17-sep-2013.Expiration date: 2018-08-31.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 clinical evaluation: femoral component (stem, head and liner) revision performed 5 years and 9 months after primary cementless total hip arthroplasty.No information concerning patient age, gender, general health status and the presence of comorbidities is available.In the radiographic image provided, radiolucent lines and signs of stress shielding are visible.Aseptic loosening is a possible literature described adverse event after primary cementless hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.
Event or Problem Description
Revision surgery for stem loosening 5 years and 9 months after primary surgery.The surgeon revised successfully the stem, head and liner.

• Brand Name: STEM: AMISTEM H 01.18.130 HA COATED STD STEM SIZE 0
• Common Device Name: HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10996079
• Report Number: 3005180920-2020-00900
• Device Sequence Number: 777835
• Product Code: LZO
• UDI-Device Identifier: 07630030804069
• UDI-Public: 07630030804069
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 01.18.130
• Device Catalogue Number: 01.18.130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/12/2020
• 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