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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS RGX PATELLA PROSTHESIS, KNEE

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BIOMET ORTHOPEDICS RGX PATELLA PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)
Event Date 06/01/2016
Event Type  Injury  
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: under possible adverse effects, number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, malposition, non-union, bone resorption and/or excessive unusual and/or awkward movement and/or activity and/or excessive weight. " number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma non-union or excessive weight. " number 15 states, "interoperative or postoperative bone fracture and/or postoperative pain. " expected, not yet received.

 
Event Description

Patient underwent a right knee revision procedure approximately two years post-implantation due to pain, loosening and the pegs of the patella shearing off.

 
Event Description

Patient reported undergoing a right knee revision procedure approximately 23 months post-implantation due to the patella component allegedly fracturing and disassociating from the pegs. A review of invoice history confirms patella button was removed and replaced. This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified. The revision operative report noted pain and discomfort of the patient and further mentioned that the patella component was loose and that the pegs had sheared from the metal backing; all fragments and debris were removed.

 
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Brand NameRGX PATELLA
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 Key5747707
MDR Text Key48099138
Report Number0001825034-2016-02270
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 COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date03/31/2019
Device MODEL NumberN/A
Device Catalogue Number141357
Device LOT Number101710
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/22/2014
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: 06/24/2016 Patient Sequence Number: 1
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