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U.S. Department of Health and Human Services

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

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BIOMET UK LTD. OXF ANAT BRG LT SM SIZE 4 PMA SML SZ 4; 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 05/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in the (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported by the hospital that a patient underwent an initial oxford knee replacement procedure.Subsequently, the hospital reported an unknown event has occurred.Further information has been requested.
 
Event Description
It was reported by a sales representative that a surgeon implanted a left bearing, instead of the right.There has been no further action taken on this incident.
 
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
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.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 was reported by a sales representative that a surgeon implanted a left bearing, instead of the right.There has been no further action taken on this incident.
 
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Brand Name
OXF ANAT BRG LT SM SIZE 4 PMA SML SZ 4
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8771144
MDR Text Key150391045
Report Number3002806535-2019-00593
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279785872
UDI-Public05019279785872
Combination Product (y/n)N
PMA/PMN Number
P010014/S028
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 09/14/2019
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 Date02/18/2024
Device Model NumberN/A
Device Catalogue Number159541
Device Lot Number6488613
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/18/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received07/09/2019
08/28/2019
Supplement Dates FDA Received07/17/2019
09/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age70 YR
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