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

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.

• 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 Key: 5621222
• MDR Text Key: 44128872
• Report Number: 3002806535-2016-00212
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• 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 Number: N/A
• Device Catalogue Number: 32-422703
• Device Lot Number: ZB150201
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1