MAUDE Adverse Event Report: BIOMET ORTHOPEDICS FEMORAL MODULAR BOX-57.5 RIGHT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

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: under care and handling of instruments, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling." under storage and shelf life, "instrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture." (b)(4).Examination of returned device found no evidence of product non-conformance and confirmed reported condition.A conclusive root cause of the event could not be determined.This report is number 2 of 16 mdrs filed for the same event (reference 1825034-2016-02214 / 02229).

Event Description

A tray of instruments was found to have rust after being sterilized.It is unknown if the rusted instruments were used during a procedure.

• Brand Name: FEMORAL MODULAR BOX-57.5 RIGHT
• Type of Device: PROSTHESIS, KNEE
• 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: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5741689
• MDR Text Key: 47936060
• Report Number: 0001825034-2016-02215
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK140883
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-360728
• Device Lot Number: 111380
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1