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

MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4; 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 UK LTD. OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problems Material Integrity Problem (2978); Naturally Worn (2988)
Patient Problem No Code Available (3191)
Event Date 09/18/2014
Event Type  Injury  
Event Description
It was reported that the patient underwent a knee replacement surgery on (b)(6), 2003.Revision procedure was performed on (b)(6), 2014 due to bearing wear.No further information has been received.
 
Manufacturer Narrative
The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Item is to be returned.Upon return of item and completion of evaluation, a follow up report will be sent to the fda.
 
Manufacturer Narrative
The oxford meniscal bearing was revised after 11 years and 5 months due to ¿bearing wear¿.It is reported that the patient fell and the bearing dislodged medially, however the date of the fall has not been reported hence it is unknown how long the bearing was functioning in this location.The severe deformation on the medial side of the inferior articulating surface suggests that the meniscal bearing was overhanging the tibial tray prior to revision.The lateral side of the superior articulating surface exhibits severe delamination and discoloration which may be indicative of femoral impingement.Both the inferior and superior articulating surfaces exhibit a large number of indentations which suggests that third body wear also may have occurred.The potential femoral edge wear and possible source of third body particles cannot be confirmed without radiographic images.An assessment of the positioning, sizing and alignment of the bearing is also unable to be made.Therefore, the ultimate cause for the adverse bearing wear cannot be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OXFORD PKS MEN BEARING UHMWPE LARGE SZ 4
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
daniel tilbury
waterton industrial estates
bridgend CF31 -3XA
UK   CF31 3XA
0441656655
MDR Report Key4173548
MDR Text Key16303002
Report Number3002806535-2014-00233
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/24/2014
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 Health Professional
Device Expiration Date10/30/2007
Device Model NumberN/A
Device Catalogue Number154635
Device Lot Number566506
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/24/2014
Initial Date FDA Received10/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2002
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;
-
-