Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS
  • 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. UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Collapse (1099)
Patient Problem Collapse (2416)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: (b)(6).Concomitant medical products: medical product: unk oxford tibial tray catalog #: not reported lot #: not reported, medical product: unk oxford bearing catalog #: not reported lot #: not reported.Additional mdr report were filed for this event, please see associated report: 3002806535-2019-00912.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00912-2.Reported event was unable to be confirmed due to limited information received from the customer.The product and lot number identification necessary to review manufacturing history and the complaint history was not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Event Description
It has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.
 
Event Description
It has been reported by the sales representative that the patient underwent initial knee arthroplasty on an unknown date.Subsequently, during regular follow up six weeks post-operative it was noticed that the cemented oxford prosthesis had collapsed for an unknown reason.A revision surgery has been planned for an unknown date.
 
Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNK OXFORD FEMORAL COMPONENT
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9436546
MDR Text Key169806438
Report Number3002806535-2019-00913
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/13/2020
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/25/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received12/02/2019
02/11/2020
Supplement Dates FDA Received12/19/2019
02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
-
-