MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI FEMORAL LG; PROSTHESIS, KNEE

Catalog Number 154602

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi# - (b)(4).Concomitant product(s): ¿ oxford anatomic bearing, catalog 159584 ,lot 399542; oxford tibial tray, catalog 154725, lot 497627.The information provided on this form was previously submitted under manufacturing report number 1825034-2014-06519.

Event Description

It was reported a patient enrolled in a clinical study underwent a right partial knee arthroplasty on (b)(6) 2008.Subsequently, patient alleges pain and migration of the femoral component.There has been no reported revision procedure to date.

• Brand Name: OXFORD UNI FEMORAL LG
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6631928
• MDR Text Key: 77273112
• Report Number: 3002806535-2017-00479
• 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: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 154602
• Device Lot Number: 1454958
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 91