MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 8; CEMENTLESS HIP STEM

Catalog Number	01.39.008
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 january 2019: lot 162116: (b)(4) items manufactured and released on 22-jun-2016.Expiration date: 2021-05-30.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
On (b)(6) 2018 we were informed that a patient came in due to instability caused by a loose stem 2 years and 1 month after the primary.On the next day the surgeon revised the stem and head with another company's product and the surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 8
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8230882
• Report Number: 3005180920-2018-01081
• Device Sequence Number: 16420681
• Product Code: LZO
• UDI-Device Identifier: 07630030885570
• UDI-Public: 07630030885570
• 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: 2016
• 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): 01/09/2019

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: 05/30/2021
• Device Catalogue Number: 01.39.008
• Device Lot Number: 162116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/09/2019
• 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