MAUDE Adverse Event Report: BIOMET MICROFIXATION PECTUS SUPPORT BAR; PECTUS BAR

Model Number N/A

Device Problem Biocompatibility (2886)

Patient Problems Dehydration (1807); Increased Sensitivity (2065); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The part and lot numbers are unknown, therefore the device history records are unable to be reviewed.The package insert for this device lists "patients presenting metal sensitivity reactions" as a contraindication.Metal sensitivity reactions or allergic reaction to the implant material are listed as possible adverse effects.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.

Event Description

A legal claim was received which indicated the patient had a revision due to an allergic reaction.The document states the surgery to place two pectus bars was performed (b)(6) 2015.The patient was inpatient for a week after the procedure.The patient was still nauseous and could not tolerate pain medicine or control urinating.The patient was in severe pain after the surgery and at one point her respiratory function severely decreased.After the bars were implanted the patient experienced more difficulty breathing and suffered from severe headaches.The patient experienced pain when urinating; the doctor prescribed septra as it sounded like a urinary tract infection.The patient reported throwing up constantly while taking septra.The patient made several trips to the emergency room due to her symptoms.It is reported based on the patient's symptoms no allergy test was performed.At one point the patient could no longer keep water down and was suffering from dehydration.It is reported she was diagnosed with anxiety and referred to a psychiatrist.The patient continued to get weaker, had increasing joint pain, continued to have severe headaches, and continued to have problems breathing, and she had developed a rash from the waist up.The patient was seen by a different physician who performed a test for allergic reactions to the metal bars which tested positive to sensitivity to the components in the bars.As a result, the bars were removed in (b)(6) 2016.After the surgery the patient's rash immediately faded, her headaches were gone as well as her chest and joint pain.It is reported the patient is still suffering from the same complications she was suffering from prior and the results are more severe than they were prior to surgery.The compression in her lungs is worse and she is rendered unable to do anything she was able to do prior and her immune system has lowered.She has now been confined to a recliner.

Event Description

The legal document states the patient is unable to finish school, work, or take care of herself.The patient had a consult with another surgeon who stated a third surgery could be a dangerous and fatal and is not a viable option right now due to the scar tissue she currently has due to the complications that the prior surgery placed on her organs.It is stated there is a strong possibility the patient will never recover from the complications of the surgery and the allergic reaction she suffered from, that she will never be able to have kids and will be rendered severely disabled for the rest of her life.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).This follow-up report is being submitted to relay additional information.These parts were removed in a revision; therefore the complaint is considered confirmed.Investigation results concluded that the reported event was due to patient condition.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.(b)(4).

Event Description

It was reported via the receipt of additional legal documents that upon one of the visits to the emergency room she was prescribed prevacid, a proton pump inhibitor, after other anti-nausea medications were tried.She showed symptoms of a serious reaction to prevacid, including high heart rate and watery diarrhea.She needed frequent emergency room visits for headache, high heart rate, and dehydration.It was reported the patient was admitted to the hospital and tested for c-diff.It was not a viable sample, but she tested positive and was treated for c-diff.She took vancomycin for approximately two months.When her vancomycin dose was doubled she began to break out in red, itchy spots all over her body from the waist up.She had diarrhea several times daily while the bars were in, which stopped immediately when they were removed.She began to smell very badly from her chest cavity.The surgeon who removed the bars washed her chest cavity out with antibiotic wash.The patient's chest pain and digestive complaints and headaches were resolved as soon as the bars were removed.Her tachycardia and erratic heart rate, not present in testing before the bars were placed, has been present ever since and severely limits her daily function.She has been diagnosed with an auto-immune disorder, triggered by her systemic allergic reaction.When her heart pounds, her pounding headaches and temporary loss of vision in one eye increases.Her physical therapists have noted that cardiovascular problems limit the physical therapy she can do, as well as daily activities.She cannot return to her polycystic ovary syndrome (pcos) medication, which should have been discontinued for surgery and she discontinued after surgery because of constant, severe chest pain, because she can no longer tolerate it.Her blood pressure increases now when she takes it.Without her pcos medication , she continues to suffer pain.Pcos can cause heart damage and diabetes if left untreated.She had to eliminate all animal products from her diet as well.Side effects of the many medications she was given while reacting to the bars, some against her expressed will, can be heart damage.

• Brand Name: PECTUS SUPPORT BAR
• Type of Device: PECTUS BAR
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7028103
• MDR Text Key: 91912632
• Report Number: 0001032347-2017-00803
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK972420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 10/17/2017; 03/23/2018
• Supplement Dates FDA Received: 11/14/2017; 04/20/2018
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 23 YR