MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7; HIP CEMENTLESS STEM

Catalog Number	01.39.207
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2019: lot 168822: (b)(4) items manufactured and released on 26 april 2017.Expiration date: 2022-04-12.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.Clinical evaluation performed by medical affairs director: hip revision surgery occurred 1 year after primary cementless total hip arthroplasty.Radiographic image provided shows the presence of a slightly varus stem.This position may be due to patient anatomy or bone morphology that cannot be assessed on the basis of a single pre-revision antero-posterior x-ray.However, no relationship can be established between the varus position and the mobilization, as it is very frequent to have varus stem performing impeccably.The very short follow up before revision surgery leads to suspect that satisfactory primary stability had not been achieved, but we cannot speculate on the reasons for this (difficulties or significant events at rehabilitation, for instance, small traumas, etc.).A final conclusion as to the reasons that led to the event cannot be reached with the information at hand.
Event or Problem Description
Revision surgery performed after 11 months from the primary due to pain caused by a loose stem.The surgeon revised the stem and head and the surgery was completed successfully.

• Brand Name: STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 7
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8711047
• Report Number: 3005180920-2019-00485
• Device Sequence Number: 2473048
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

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: 04/12/2022
• Device Catalogue Number: 01.39.207
• Device Lot Number: 168822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• 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