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

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 02/01/2009

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 article was written by b kerens, m.G.M schotanus, b.Boonen, p.Boog, p.J.Emans, h.Lacroix, and n.P.Kort.There are warnings in the package insert that state that this type of event can occur: under warnings, number 1 states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of prosthetic components." product location unknown.

Event Description

Information was received based on review of a journal article titled, "cementless versus cemented oxford unicompartmental knee arthroplasty: early results of a non-designer user group" which aimed to examine the differences of tibial radiolucent line between cementless and cemented implants and to investigate the survival rate by comparing the perioperative data and clinical results.A patient was identified in the article that underwent a revision procedure approximately eleven months post-implantation due to femoral malpostioning.All components were removed and replaced with total knee components.There has been no further information provided and the patient outcome is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

• Brand Name: UNKNOWN OXFORD FEMORAL COMPONENT
• 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: 5847937
• MDR Text Key: 51192071
• Report Number: 3002806535-2016-00655
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• 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