MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TIB TRAY SZ B RM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395); Unstable (1667); Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); Joint Swelling (2356); Numbness (2415)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

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.There are warnings in the package insert that state that this type of event can occur: 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 13 states, "dislocation and subluxation due to inadequate fixation and improper positioning." number 20 states, "persistent pain." this report is number 1 of 3 mdrs filed for the same event (reference 1825034-2015-04567 / 04568 / 04569).

Event Description

It was reported that patient underwent right partial knee arthroplasty on (b)(6), 2012.Subsequently, patient was revised on (b)(6), 2015 due to pain, swelling, numbness, clicking, and instability.All components were removed and replaced with total knee components.Operative notes received further report that during the procedure asymmetrically increased blood flow and diffuse uptake were noted.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being filed to correct information.This report is number 1 of 3 mdr's filed for the same event (reference 1825034-2015-04567 / 04568 / 04569).

• Brand Name: OXF UNI TIB TRAY SZ B RM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend, south wales IN CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5207458
• MDR Text Key: 30605517
• Report Number: 0001825034-2015-04567
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 154721
• Device Lot Number: 2652849
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2012
• 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: 49 YR