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

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fall (1848); Damage to Ligament(s) (1952); Joint Dislocation (2374)

Event Type  Injury  

Manufacturer Narrative

This user facility is outside of the united states.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.The following sections could not be completed with the limited information provided: date of event - ni.Brand name ¿ ni.Device info - ni.Date implanted - ni.Date explanted - ni.Initial reporter - the article was written by n.Hooper, d.Snell, g.Hooper, r.Maxwell, and c.Frampton.Manufacture date ¿ ni.Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.Product location unknown.

Event Description

Information was received based on review of a journal article titled, "the five-year radiological results of the uncemented oxford medial compartment knee arthroplasty" which aimed to examine the functional outcomes and faster recovery with few complications of the cementless unicompartmental knee arthroplasty and to investigate the frequency of radiolucent lines on radiographs compared to a cemented unicompartmental knee.A patient was identified in the article that reportedly fell, causing the anterior cruciate ligament to rupture.It was further reported the patient fell a second time causing the polyethylene bearing to dislocate.Subsequently, the patient underwent a revision procedure.The polyethylene bearing was removed and replaced.There has been no further information provided and the patient outcome is unknown.

• Brand Name: UNKNOWN OXFORD 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: 5844672
• MDR Text Key: 51108928
• Report Number: 3002806535-2016-00647
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2016
• 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