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

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Failure to Osseointegrate (1863)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.Initial reporter - this article was written by a.D.Liddle, h.G.Pandit, c.Jenkins, p.Lobenhoffer, w.F.M.Jackson, c.A.F.Dodd, and d.W.Murray.Device location unknown.

Event Description

Information was received based on a review of a journal article titled, ¿valgus subsidence of the tibial component in cementless oxford unicompartmental knee replacement,¿ which aimed to examine the clinical and radiological findings of patients whose tibial component subsides into a valgus positions with an increased posterior slope before becoming well-fixed.The situation appears to be avoidable by minor modifications to the operative technique, and it appears that it can be treated conservatively in most patients.It has been reported in the journal article that a patient experienced pain and subsidence and was subsequently revised.During the revision procedure, the tibial component was found to be loose with lack of bony ingrowth.The tibial component was removed and replaced.

• Brand Name: UNKNOWN OXFORD CEMENTLESS 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: 5779329
• MDR Text Key: 49076501
• Report Number: 3002806535-2016-00547
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 66 YR