MAUDE Adverse Event Report: BIOMET UK LTD OXF UNI TIB TRAY SZ AA LM PMA; PROSTHESIS, KNEE

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Toxicity (2333)

Event Date 05/26/2015

Event Type  Injury  

Event Description

It was reported that patient underwent left partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to radiolucency and pain.During the revision, a loose tibial tray and metallosis in the synovium were noted.All components were removed and replaced with a total knee system.

Manufacturer Narrative

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.There are warnings in the package insert that state that this type of event can occur: "persistent pain." "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." "material sensitivity reactions.".

Manufacturer Narrative

This follow-up report is being filed to correct information.Discarded.

• Brand Name: OXF UNI TIB TRAY SZ AA LM PMA
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD; waterlon industrial estate; bridgend, south wales
• 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: 4859494
• MDR Text Key: 5847073
• Report Number: 0001825034-2015-02532
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 159531
• Device Lot Number: 2928133
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2013
• 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: 65 YR