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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; PROSTHESIS, KNEE

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BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; PROSTHESIS, KNEE Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2016
Event Type  malfunction  
Manufacturer Narrative
This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reportedly available for evaluation; however, it has not been received by zimmer biomet uk to date.In the event that the device is received and evaluated, a follow-up report will be sent to the fda to provide results.There are warnings in the package insert that these types of events may occur.Under precautions, number 5 states, "intraoperative fracture or breaking of instruments has been reported.Surgical instruments are subject to wear with normal usage.Instruments, which have experienced extensive use or excessive force, are susceptible to fracture.Surgical instruments should only be used for their intended purpose.Biomet recommends that all instruments be regularly inspected for wear and disfigurement." return expected, not yet received.
 
Event Description
It was reported that patient underwent a right partial knee arthroplasty on (b)(6) 2016.During the procedure, the edges of the tibial bearing trial fractured.No pieces fell into the patient and all pieces were retrieved without patient injury.Another trial bearing was available to complete the procedure without delay.
 
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Brand Name
OXF TRL BRG W/SLOTS MED 3MM
Type of Device
PROSTHESIS, KNEE
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
daniel tilbury
waterton industrial estates
bridgend CF31 -3XA
UK   CF31 3XA
0441656655
MDR Report Key5621222
MDR Text Key44128872
Report Number3002806535-2016-00212
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
PP010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberN/A
Device Catalogue Number32-422703
Device Lot NumberZB150201
Other Device ID NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2016
Initial Date FDA Received04/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberN/A
Patient Sequence Number1
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