PYROCARBON HUMERAL HEAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for PYROCARBON HUMERAL HEAD manufactured by Tornier, Inc.

Event Text Entries

[128393679] Dr (b)(6) at (b)(6) hosp in (b)(6), solicited me to volunteer for a clinical trial to determine if a tornier corp pyrocarbon humeral head can replace a traditional shoulder replacement with a metal humeral head and a rebuilt glenoid socket. He was not forthright in explaining that a primary purpose of this clinical trial is to determine if a pyrocarbon humeral head can avoid the expensive and short-lived rebuilding of the glenoid cavity to accommodate a metal humeral head. The ide study protocol is entitled (b)(6) study ((b)(6)). The investigational device is called the aequalis pyrocarbon humeral head. Due to the age-related, misshaped condition of my glenoid cavity, as well as inadequate cartilage, it was the opinion of dr (b)(6) at (b)(6) hosp in (b)(6) that i was not a candidate for this clinical trial. He wanted to do the surgery on me using a traditional metal humeral head. However, dr (b)(6) explained to me that dr (b)(6) would not know whether i was a candidate for this clinical trial because he did not attend the (b)(6) clinical trial conference. He advised the pyrocarbon humeral head would have at least twice the life span of a metal humeral head and would not require glenoid resurfacing. That did not prove to be the case in my situation and i want to make sure if the device does get fda approval that they qualify the approval as being limited to individuals with uncompromised glenoid sockets. Otherwise, like me, it may not fit, will constantly shift, slide, allow limited motion and result in further damage to the shoulder area. I had this surgery almost two years ago and now am in almost constant pain. Last year dr (b)(6) told me he would remove the pyrocarbon device, when i could no longer bear the expected pain. He said he would replace it with a metal humeral head and rebuild my glenoid socket. Now with damage caused to my glenoid socket by the pyrocarbon humeral head he is reluctant to take out the experimental device. Dr (b)(6) was right, i was not a suitable candidate for this clinical trial and they should not have used me for this study.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081549
• MDR Report Key: 8099838
• Date Received: 2018-11-19
• Date of Report: 2018-11-05
• Date of Event: 2018-10-20
• Date Added to Maude: 2018-11-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: PYROCARBON HUMERAL HEAD
• Generic Name: PROSTHESIS, SHOULDER
• Product Code: MJT
• Date Received: 2018-11-19
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: TORNIER, INC

Device Sequence Number: 1

• Brand Name: PYROCARBON HUMERAL HEAD
• Generic Name: PROSTHESIS, SHOULDER
• Product Code: MJT
• Date Received: 2018-11-19
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TORNIER CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-11-19