• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RGX 3 PEG SER A PAT -31MM PROSTHESIS, KNEE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET ORTHOPEDICS RGX 3 PEG SER A PAT -31MM PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Bearings (734); Degraded (1153); Migration or Expulsion of Device (1395)
Patient Problems Inflammation (1932); Pain (1994); Swelling (2091); Reaction (2414); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 09/03/2014
Event Type  Injury  
Event Description

Patient's legal counsel reported patient underwent right total knee arthroplasty on (b)(6) 2011. Legal counsel further reports patient underwent revision procedure on (b)(6) 2014 due to patient allegations of pain, swelling, inflammation, and loss of mobility. A review of invoice history confirmed both surgery dates and that the tibial bearing and polyethylene patella were replaced during the revision surgery. This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.

 
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: "interoperative or postoperative bone fracture and/or postoperative pain. " "inadequate range of motion due to improper selection or positioning of components. " this report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions. ¿ number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption or excessive activity. " number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain. " product location unknown.

 
Event Description

Patient's legal counsel reported patient underwent right knee revision procedure approximately three years post-implantation due to patient allegations of pain, swelling, inflammation, and loss of mobility. This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified. Additional information received in patient's medical records indicates patient underwent a right knee revision procedure approximately 3 years post-implantation due to pain, mechanical failure and metallosis. During the procedure, swelling, effusion, aspiration of fluid, fibrous tissue, migration of the patellar component, debris and dark gray staining with gray inclusions in the acetabular liner were noted. The tibial bearing and patellar component were removed and replaced to complete the procedure.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. This report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2015-02709 and 03583 and 03586).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRGX 3 PEG SER A PAT -31MM
Type of DevicePROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key4866291
MDR Text Key6046399
Report Number0001825034-2015-02709
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK083782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup
Report Date 08/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date03/31/2015
Device MODEL NumberN/A
Device Catalogue Number141356
Device LOT Number248300
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/02/2010
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/24/2015 Patient Sequence Number: 1
-
-