MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM C CEMENTED STD STEM SIZE 3; CEMENTED HIP STEM

Catalog Number	01.18.153
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 may 2018; lot 155566: (b)(4) items manufactured and released on 07 october 2015.Expiration date: 2020-09-22.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 performed by medical affairs on 04 may 2018; while proceeding towards tha, the surgeon noticed that the contralateral hip is radiographically loose, although not painful and therefore no action was taken.From the image provided, an unexpected bone reaction is visible, which may lead to the decision of verifying possible metabolic or local disorders.We have no former images and hence no further analysis can be performed at this stage.
Event or Problem Description
The surgeon noticed loosening radiographically 1 year and 8 months after primary.The patient is not in pain and will not be revised.

• Brand Name: AMISTEM C CEMENTED STD STEM SIZE 3
• Common Device Name: CEMENTED HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7506731
• Report Number: 3005180920-2018-00322
• Device Sequence Number: 1788612
• Product Code: LZO
• UDI-Device Identifier: 07630030804281
• UDI-Public: 07630030804281
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 09/22/2020
• Device Catalogue Number: 01.18.153
• Device Lot Number: 155566
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 06/07/2018
• 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