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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; PROSTHESIS, KNEE
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BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Tissue Breakdown (2681)
Event Date 09/27/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
 
Event Description
It was reported the patient was revised due to posterior tibial collapse.No further information has been made available.
 
Manufacturer Narrative
(b)(4).On reviewing complaint history it was discovered that this complaint is a duplicate of (b)(4).The product has been returned under (b)(4) and a pce(product complaint evaluation) has been assigned for evaluation.Therefore this complaint (b)(4) will be moved to 'not a complaint' as a duplicate of (b)(4).
 
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Brand Name
OXF UNI TIB TRAY SZ B LM PMA
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key6980526
MDR Text Key90346381
Report Number3002806535-2017-00979
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number154720
Device Lot Number299710
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Date Manufacturer Received04/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
THE 159550 OXF ANAT BRG LT MD SIZE 6 PMA LOT 148940; THE 161469 OXF TWIN-PEG CMNTD FEM MD PMA LOT UNK; THE 159550 OXF ANAT BRG LT MD SIZE 6 PMA LOT 148940; THE 161469 OXF TWIN-PEG CMNTD FEM MD PMA LOT UNK
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age61 YR
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