MAUDE Adverse Event Report: EBI, LLC. BIOMET EBI BONE HEALING SYSTEM; BONE GROWTH STIMULATOR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); No Code Available (3191); Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the lot was released with no recorded anomaly or deviation.The product was not be returned for an evaluation by the patient.Without a product return, no product evaluation is able to be conducted.Zimmer biomet's manager of r&d for biologics and electrical stimulation (rdbes manager) who is a phd spoke with the patient and advised we don¿t know of any link of lateral sacroiliitis, lupus or sterility and our devices with getting cancer and we do not have any documented reports of our devices causing cancer in any patients.In addition, since the cyst is not near where the device was treating and given the long use profile for pulse electromagnetic field (pemf) stimulation, the patient's symptoms are unrelated to the device.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.

Event Description

The patient was provided the bone healing system (bhs) on (b)(6) 2015.The patient reported she has finished treatment on her humerus with the bhs.The patient voiced concern to zimmer biomet customer service about the bhs being linked to cancer.The patient advised she found out she has a cyst on her ovary but nothing was diagnosed.The patient later reported she is currently going to a specialist for a second opinion to be seen for uterine cancer.The patient advised she knows of three other women who have used the bhs and experienced the same symptoms she experienced.She advised these women have developed uterine cancer.The patient advised her surgeon told her the bhs does more good than harm.The patient advised that her doctor told her that if the device is used with a patient who has lateral sacroiliitis, this can cause cancer.The patient's sales representative advised the doctor stated that he did not tell the patient the bhs causes cancer.The patient spoke with the manager of r&d for biologics and electrical stimulation (rdbes) for zimmer biomet about her concerns.The patient advised the rdbes manager that she recognizes the device is good for men but not safe for women.She advised the rdbes manager that people with sacroiliitis, lupus, and who are sterile should not use the device as it can cause cancer.

• Brand Name: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: BONE GROWTH STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 6300833
• MDR Text Key: 66493631
• Report Number: 0002242816-2017-00004
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP790002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068234
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability