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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. UNK OXFORD TIBIAL TRAY; KNEE PROSTHESIS
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BIOMET UK LTD. UNK OXFORD TIBIAL TRAY; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Seroma (2069)
Event Date 08/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: unk oxford femoral 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: 3002806535-2019-00910, 3002806535-2019-00911.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported patient underwent a left tka.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and deridement of left knee with polyethylene component exchange.
 
Event Description
It was reported patient underwent a left tka.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and deridement of left knee with polyethylene component exchange.
 
Manufacturer Narrative
(b)(4).D10: attempts were made to obtain additional information.However, none was available.D11: medical product: unknown oxford femoral component, catalog #: unknown, lot #: unknown.Medical product: unknown oxford bearing, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00910-1, 3002806535-2019-00911-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as it is unavailable.A review of the complaint database could not be performed as item number is unavailable.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, the root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time if any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Event Description
It was reported patient underwent a left total knee arthroplasty.Subsequently, patient was revised due to seroma and pain.The procedure included irrigation and deridement of left knee with polyethylene component exchange.
 
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-009010-2, 3002806535-2019-00911-2.Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current manufacturer.This event will be reported by medwatch facility warsaw biomet ¿ (b)(4).
 
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Brand Name
UNK OXFORD TIBIAL TRAY
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9415508
MDR Text Key169213204
Report Number3002806535-2019-00909
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
Patient Weight154
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