MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD TIBIAL TRAY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); No Information (3190)

Event Date 08/26/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient underwent knee revision approximately 5 months post-implantation due to tibial tray subsidence, aseptic loosening, and collapse.Patient was converted from partial to total knee system.

Manufacturer Narrative

(b)(4).Medical devices: oxford bearing, cat#: 159549 lot#: 2845936; oxford cementless femoral, cat#: 161474 lot#: 2407049.

Event Description

Patient experiencing pain and possible movement of the tibial component.Radiographs show position change of the tibial implant from 4 degrees slope to 10 degrees, from 2 degrees valgus to 10 degrees.The patient is being treated with medication and physical exercises.

• Brand Name: OXFORD TIBIAL TRAY
• 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: 6694559
• MDR Text Key: 79357963
• Report Number: 3002806535-2017-00558
• 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,Followup
• Report Date: 08/08/2017

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 Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: US166575
• Device Lot Number: 3050475
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 06/09/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2013
• 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: 74 YR
• Patient Weight: 79