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

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)

Patient Problems Arthritis (1723); Unspecified Infection (1930); Necrosis (1971); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

An oxford knee study was reported in a journal article regarding the outcomes of 30 knees, 29 biomet and 1 zimmer, revised to total knee arthroplasties.In 15 cases, the reason for revision was listed as unknown, 8 cases were listed as progression of osteoarthritis of the lateral or patellofemoral compartment, 2 were tibial component loosening, 1 was malposition of the femoral component, one was revised for infection, and one for osteonecrosis of the lateral compartment.Knees were revised to vanguard knees or lcs total knee system implants.No further information has been received.

Manufacturer Narrative

The user facility is outside of the united states.No medwatch report was received.No product was returned.No conclusion can be made as to the cause of the events.The sections could not be completed as the information involves multiple revisions/patients and/or is unknown: dates of events, expiration dates, dates implanted, dates explanted, initial reporter, manufacture dates.

• Brand Name: OXFORD KNEE IMPLANTS
• 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: sian rogers ; waterton industrial estates; bridgend CF31 -3XA ; UK CF31 3XA ; 0441656655
• MDR Report Key: 4006673
• MDR Text Key: 4708285
• Report Number: 3002806535-2014-00183
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• 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