MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN KNEE; PROSTHESIS, KNEE

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/14/2008

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Sections could not be completed with the limited information provided: initial reporter - the article was written by omar k.Alnachoukati, keith berend, mike kolczun, roger emerson, adolf lombardi, david mauerhan, and john barrington.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "multi-center study of 825 phase iii oxford medial compartmental arthroplasty knees: an average ten-year survival analysis in the united states." which aimed to examine the first long-term survivorship with a large patient sample size study in the united states looking at various aspects of the phase iii oxford design while also addressing recent advancements that can help aid the uka process and improve partial knee survivorship.A patient was identified that underwent a left partial knee arthroplasty.Patient follow-up results provided indicates the patient underwent a revision procedure approximately three years post-implantation in order to remove cement.The bearing was removed and replaced.

• Brand Name: UNKNOWN KNEE
• 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: 5763539
• MDR Text Key: 48618822
• Report Number: 3002806535-2016-00485
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 91