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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 7 PMA; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF ANAT BRG RT LG SIZE 7 PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Code Available (3191)
Event Date 09/29/2015
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 10 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 13 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.".
 
Event Description
It was reported that patient underwent an initial right partial knee arthroplasty on (b)(6) 2015.Subsequently, the patient underwent a revision procedure on (b)(6) 2015 due to dislocation.The bearing was removed and replaced.
 
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 2 mdrs filed for the same event (reference 1825034-2015-04381-1 / 2016-00050).
 
Event Description
It was reported that patient underwent an initial right partial knee arthroplasty on (b)(6), 2015.Subsequently, the patient underwent a revision procedure on (b)(6), 2015 due to dislocation.The bearing was removed and replaced.Additional information received reported patient underwent a revision procedure on (b)(6) 2015 due to dislocation.During the procedure, patient was revised to a total knee system.
 
Manufacturer Narrative
This follow-up report is being filed to correct information.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04381-1 / 2016-00050).Requested but not returned by hospital.
 
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Brand Name
OXF ANAT BRG RT LG SIZE 7 PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend IN CF31 3XA
UK  CF31 3XA
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 Key5166668
MDR Text Key28901514
Report Number0001825034-2015-04381
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Followup,Followup
Report Date 03/04/2016
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
Device Operator Physician
Device Expiration Date02/28/2019
Device Model NumberN/A
Device Catalogue Number159586
Device Lot Number568270
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/05/2016
04/01/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2014
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age58 YR
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