MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI X SML ANATOMIC BEARING RT 3MM; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Separation (1562); Naturally Worn (2988)

Patient Problem No Code Available (3191)

Event Date 10/14/2015

Event Type  Injury  

Manufacturer Narrative

This user facility is outside the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Implant date - approximately 5 years ago.There are warnings in the package insert that state 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 the prosthetic components.".Under possible adverse effects, number 10 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 16 states, "wear and/or deformation of articulating surfaces.".

Event Description

It was reported that patient underwent a right partial knee arthroplasty approximately 5 years ago.Subsequently, a revision procedure was performed on (b)(6) 2015 due to wear and disassociation of the tibial bearing.

• Brand Name: OXFORD UNI X SML ANATOMIC BEARING RT 3MM
• 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: 5304304
• MDR Text Key: 33702412
• Report Number: 3002806535-2015-04168
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2015
• Device Model Number: N/A
• Device Catalogue Number: 160790
• Device Lot Number: 1964590
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2010
• 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: 76 YR