MAUDE Adverse Event Report: BIOMET ORTHOPEDICS OSS TIB TRAY 63X100MM; ORTHOPEDIC SALVAGE SYSTEM

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening, migration, or fracture of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity." number 9 states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight." medical product - intramedullary plug lge, catalog#: 130613 lot#: 423370; oss rs poly tibial bearing 12, catalog#: 161028 lot#: 116580; oss rs poly fem bushings set/2, catalog#: 161034 lot#: 514240; oss poly lock pin, catalog#: 150478 lot#: 867330; oss poly tibial bushing, catalog#: 150476 lot#: 561550.Therapy date ¿ unknown date in 2017.This report is number 1 of 16 mdrs filed for the same patient (reference 1825034-2017-00765 / 00766 / 00767 / 00777 / 00825 - 00835).

Event Description

Patient has been indicated for revision of orthopedic salvage knee and hip components due to radiographic evidence depicting fractured fragments loose in the joint.It is unknown at this time which components have fractured.No revision has been reported to date.

• Brand Name: OSS TIB TRAY 63X100MM
• Type of Device: ORTHOPEDIC SALVAGE SYSTEM
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6350161
• MDR Text Key: 68049261
• Report Number: 0001825034-2017-00765
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PCUSTOM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2015
• Device Model Number: N/A
• Device Catalogue Number: CP112835
• Device Lot Number: 659640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2005
• 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): Other