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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; KNEE PROSTHESIS

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BIOMET UK LTD. OXF ANAT BRG LT LG SIZE 4 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 06/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz e lm pma catalog #: 154726 lot #: 765110, medical product: oxf twin-peg cmntd fem lg pma catalog #:161470 lot #: 529580.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00588, 3002806535-2019-00587.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that a patient underwent an initial left knee procedure.Subsequently, the patient was revised due to unknown reason.
 
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
Revision due to lateral wear.
 
Event Description
It was reported that a patient underwent revision due to lateral wear.
 
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.Device history record (dhr) was reviewed and no discrepancies were found in relation to this reported event.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.
 
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Brand Name
OXF ANAT BRG LT LG SIZE 4 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8770626
MDR Text Key150368130
Report Number3002806535-2019-00586
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279786015
UDI-Public05019279786015
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,health
Type of Report Initial,Followup,Followup
Report Date 08/21/2019
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 Expiration Date05/11/2022
Device Model NumberN/A
Device Catalogue Number159555
Device Lot Number079140
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/01/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received07/10/2019
08/15/2019
Supplement Dates FDA Received07/19/2019
08/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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