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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; UNICONDYLAR KNEE PROSTHESIS
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BIOMET UK LTD. OXF UNI TIB TRAY SZ B LM PMA; UNICONDYLAR KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Pain (1994); Impaired Healing (2378)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: oxf twin-peg cmntd fem md pma em med, catalog #: 161469, lot #: 279290.Medical product: oxf anat brg lt md size 6 pma med sz 6, catalog #: 159550, lot #: 2981359.Medical product: oxford res aesculap 3ti 3pk, catalog #: 506296, lot #: 95y156.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00330, 3002806535-2020-00331.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported the patient underwent a left total knee arthroplasty.Subsequently the patient states to have been revised due to pain and implant failure.Patient stated the implant went bad three to four months after initial surgery.It had shifted, deteriorated and the bottom bone was coming out of the let.Pieces of the device had shredded.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00330-1, 3002806535-2020-00331-1.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 4 similar complaints reported with the item: 154720, 16 similar complaints reported with the item: 161469 and no similar complaints reported with the item: 159550.No trends were identified for the items: 154720 and 159550.For item: 161469, 4 complaints were reported with 2 similar hospital.In most cases, cause could not be determined.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to pain and implant failure.Risk management report documents the estimated residual risk associated with the device within the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.Pain is documented as a potential harm as an outcome of a number of hazards assessed by the rmf.Pain is considered a severity of 3: moderate, which as per the severity table listed within the rmr is defined as prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The reported event also states implant failure.As it is not possible to determine the cause of implant failure in this instance without provision of further information, a risk table line cannot be assigned.The outcome of this complaint is considered to be within the severity of the rmr.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.
 
Event Description
It was reported the patient underwent a left total knee arthroplasty.Subsequently the patient states to have been revised due to pain and implant failure.Patient stated the implant went bad three to four months after initial surgery.It had shifted, deteriorated and the bottom bone was coming out of the let.Pieces of the device had shredded.
 
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Brand Name
OXF UNI TIB TRAY SZ B LM PMA
Type of Device
UNICONDYLAR KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key10294568
MDR Text Key201889107
Report Number3002806535-2020-00329
Device Sequence Number1
Product Code NRA
UDI-Device Identifier05019279388868
UDI-Public05019279388868
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
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number154720
Device Lot Number469230
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Weight84
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