MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN STANDARD 4MM BEARING; PROTHESIS, KNEE

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Toxicity (2333)

Event Date 06/08/2015

Event Type  Injury  

Event Description

It was reported that patient underwent an partial knee arthroplasty on an unknown date.Subsequently, the patient was revised on (b)(6) 2015 due to bearing dislocation.The bearing was removed and replaced.During the procedure it was noted that there was osteophytes/calcium deposits as well as when the bearing was inspected there was small amounts of metallosis present.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.Current information is insufficient to permit a conclusion as to the cause of the event.No further complications have been reported.Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be sent to the fda.The following sections could not be completed with the limited information provided: product id - unknown.Device info - unknown.Date implanted - unknown.Pma/510(k) number ¿ unknown.Manufacture date ¿ unknown.

Manufacturer Narrative

Evaluation of device found evidence of posterior impingement or wear against the bone, possibly the result of improper size selection of the tibial tray or the result of patient anatomy as there were osteophytes/calcium deposits removed.Evaluation further noted that this instance should not be considered a failure since the device was implanted and in use for 19 years while the patient was very active.

• Brand Name: UNKNOWN STANDARD 4MM BEARING
• Type of Device: PROTHESIS, 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: 4884056
• MDR Text Key: 6043824
• Report Number: 3002806535-2015-00287
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention