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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS

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BIOMET UK LTD. UNK OXFORD FEMORAL COMPONENT; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems No Information (3190); No Code Available (3191)
Event Date 09/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: unk oxford tibial component, catalog #: not reported, lot #: not reported; medical product: unk oxford bearing, catalog #: not reported, lot #: not reported.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00766, 3002806535-2019-00767.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, a revision procedure due to unknown reason was performed.
 
Event Description
It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, a revision procedure due to lateral wear was performed.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.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.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial left knee replacement procedure.Subsequently, a revision procedure due to lateral wear was performed.
 
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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 Key9103995
MDR Text Key159601339
Report Number3002806535-2019-00765
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
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 Model NumberN/A
Device Catalogue NumberUNK OXFORD FEMORAL COMPONENT
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/16/2019
Initial Date FDA Received09/23/2019
Supplement Dates Manufacturer Received09/24/2019
12/03/2019
Supplement Dates FDA Received11/19/2019
12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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