MAUDE Adverse Event Report: BIOMET, INC.; HOWMEDICA OSTEONICS CORP 1. GIL QUICKANCHOR PLUS. 2. OSS INTERLOCK LOWED IM STEM WITH SCREWS.; STAPLE, FIXATION, BONE

Catalog Number 1. 222983. 2. 1

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

Clinical adverse event received for loosening of both the femoral and tibial components with migration.Event is serious and is considered severe.Event is definitely related to device and definitely not to procedure.Original implant date (b)(6) 2017.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1. GIL QUICKANCHOR PLUS. 2. OSS INTERLOCK LOWED IM STEM WITH SCREWS.
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): BIOMET, INC.; HOWMEDICA OSTEONICS CORP
• MDR Report Key: 17537261
• MDR Text Key: 321451521
• Report Number: MW5144141
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1. 222983. 2. 1
• Device Lot Number: 1. 3908414. 2. 463100.
• Patient Sequence Number: 1