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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ D LM PMA; KNEE PROTHESIS

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BIOMET UK LTD. OXF UNI TIB TRAY SZ D LM PMA; KNEE PROTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 12/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: unk oxford femoral component, catalog #: unknown, lot #: unknown, medical product: unk oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032, 3002806535-2020-00033.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure due to unknown reason was performed.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032-1, 3002806535-2020-00033-1.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.There were no trends identified from the complaint history review.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 that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to the patient developing gout.
 
Manufacturer Narrative
(b)(4).This final/follow-up report is being submitted to relay additional information.D11: medical product: oxf twin-peg cmntd fem md pma, catalog#: 161469, lot#: 540420.Medical product: oxf anat brg lt md size 4 pma, catalog#: 159548, lot#: 230390.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00032-2, 3002806535-2020-00033-2.Initial and revision procedures were performed at different hospital, within the same hospital system, by the same surgeon.Reason for revision: gout development in patient.As the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A risk assessment has not been performed for the reported event as disease progression (gout) is not device-related.A review of the complaint database has found 1 similar complaint for the item code: 154724, 6 similar complaints for the item code: 161469 and no similar complaints reported with the item: 159548.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in the cause.In most cases of similar complaints, the cause could not be established.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.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 that the patient underwent an initial left knee arthroplasty.Subsequently, a revision procedure was performed due to gout development in patient.
 
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Brand Name
OXF UNI TIB TRAY SZ D LM PMA
Type of Device
KNEE PROTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9615415
MDR Text Key175838497
Report Number3002806535-2020-00031
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/26/2020
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number154724
Device Lot Number117760
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/27/2019
Initial Date FDA Received01/22/2020
Supplement Dates Manufacturer Received01/23/2020
01/27/2020
Supplement Dates FDA Received02/17/2020
02/26/2020
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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