MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6; HIP CEMENTLESS STEM

Catalog Number	01.39.006
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 24 november 2017: ten months after implantation, the patient was complaining of instability.During revision surgery the stem was well fixed and the surgeon decided to change the femoral head.According to the report the stem slightly subsided.A single radiographic projection without indication of time was provided and evaluation of potential implant migration is not possible.On the basis of information provided, the reason of this event cannot be determined.Batch review performed on 04 december 2017: lot 162764: (b)(4) items manufactured and released on 13 june 2016.Expiration date: 2021-06-02 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.
Event or Problem Description
The patient came in complaining of instability.The surgeon determined that the stem had slightly subsided.The surgeon swapped the head and implanted an option sleeve with another head.The stem was not revised as it is now stable.

• Brand Name: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7086820
• Report Number: 3005180920-2017-00726
• Device Sequence Number: 13669160
• Product Code: LZO
• UDI-Device Identifier: 07630030885556
• UDI-Public: 07630030885556
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: 06/02/2021
• Device Catalogue Number: 01.39.006
• Device Lot Number: 162764
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• 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