MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMICMENISCAL BEARING LEFT 5MM THICK; PROSTHESIS, KNEE

Model Number N/A

Device Problems Material Erosion (1214); Unstable (1667)

Patient Problem No Information (3190)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.(b)(4).Concomitant products¿ oxford tibial tray size c catalog 154722, lot 1509511; oxford femoral small catalog 154600, lot 1368028.

Event Description

Patient underwent a left partial knee revision procedure due to valgus deformity.Posteromedial wear was noted on the tibial bearing after explantation.

• Brand Name: OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMICMENISCAL BEARING LEFT 5MM THICK
• 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: 6230693
• MDR Text Key: 64119976
• Report Number: 3002806535-2017-00013
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: N/A
• Device Catalogue Number: 159542
• Device Lot Number: 1379829
• Other Device ID Number: SEE NARRATIVE IN H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2007
• 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