MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MASTERLOC FEMORAL STEM; CEMENTLESS FEMORAL STEM

Catalog Number	01.39.207
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 july 2018: lot 166782: (b)(4) items manufactured and released on 19 january 2017.Expiration date: 2022-01-10.No anomalies found related to the issue.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During surgery the surgeon implanted the real stem and cracked the calcar.The surgeon felt the implant did not match the broach and due to the compromised bone and wire to fix the fracture he decided to go with a cemented size 4 standard stem.The cementless stem was discarded.No delay.
Additional Manufacturer Narrative
Dimensional analysis performed on september 13 by quality control manager.From the documentation of lot, don't emerge anomalies; the whole dossier of manufacture is conforming to the specific project.The dimensional control, has not identified any anomaly or production defect.The device are conforming to the specifications of project.Visual inspection performed by r&d product manager on 14 september 2018 dimensional analysis of the stem has been requested.The analysis did not highlight any non-conformity in the dimensional analysis.Broach dimensional analysis should be performed, but the component is not available.

• Brand Name: MASTERLOC FEMORAL STEM
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7734721
• Report Number: 3005180920-2018-00589
• Device Sequence Number: 19062588
• Product Code: LZO
• UDI-Device Identifier: 07630030885679
• UDI-Public: 07630030885679
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 01/10/2022
• Device Catalogue Number: 01.39.207
• Device Lot Number: 166782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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