MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE; TM GLENOID COMPONENT 46 MM ARTICULAR SURFACE

Model Number N/A

Device Problems Fracture (1260); Metal Shedding Debris (1804)

Patient Problem Test Result (2695)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation in process.

Event Description

It was observed that the patient's implant had fractured.Due to this condition the patient was revised on (b)(6) 2016 due to severe metallosis.

Manufacturer Narrative

The tm glenoid is confirmed as fractured; however, it was manufactured, inspected and packaged within established process specifications.Patient is a (b)(6) female (at the time of the revision surgery) with a medium build and low activity level.No weight or height was reported.The patient denies any trauma to the shoulder.The tm glenoid was implanted for approximately 3 years, 7 months.The index and revision surgeries were performed by 2 different surgeons located in different states.The humeral head was found to be compatible with the tm glenoid that was implanted.The tm glenoid was implanted cementless which is contrary to the surgical technique when implanted in the usa.As part of the engineering investigation, macroscopic and microscopic review of the returned device under the light microscope was conducted.The images tend to indicate that it was likely that the cruciate keel and poly articulating surfaces separated after fracturing based upon the prevalence of compressed trabecular metal struts in the area surrounding the location where the cruciate keel was once attached.Compressed metal struts can occur as a result of tm to tm (mismatch between fractured surfaces) or tm to metallic humeral head contact.No biological tissue ingrowth into the tm baseplate was suspected which may indicate the presence of a gap between the native glenoid and the tm glenoid at some point in time.The entire outer edge of the poly articulating surface appeared sharp and crisp; therefore, humeral head subluxation was not suspected.Metallosis in the periarticular tissue was reported by the surgeon and shown in the intraoperative photograph that accompanied the complaint.This engineering investigation found that the metallosis approximated the location of the relatively large cluster of radiopaque particles noted in the patient x-ray.Additional engineering review of the x-ray may indicate reduced bone density in the area immediately superior to the tm glenoid given the darker shading in that in that image area when compared to the lighter shading of the native bone located inferior and medial to the tm glenoid.The package insert, included with every device distributed, warns against using this device if the bone quality is poor.Given the lack of information, including but not limited to, a complete x-ray series and intraoperative notes, this engineering investigation is inconclusive as to the absolute root cause of failure for the tm glenoid described in complaint (b)(4).This investigation is considered closed at this time; however, should additional information become available, this report can be updated.

Event Description

Revision surgery due to severe metallosis.

• Brand Name: TRABECULAR METAL GLENOID COMPONENT 46 MM ARTICULAR SURFACE
• Type of Device: TM GLENOID COMPONENT 46 MM ARTICULAR SURFACE
• Manufacturer (Section D): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer (Section G): ZIMMER TMT; 10 pomeroy road; parsippany NJ 07054
• Manufacturer Contact: william hara ; 10 pomeroy road; parsippany, NJ 07054 ; 9735760032
• MDR Report Key: 5804884
• MDR Text Key: 50728450
• Report Number: 3005751028-2016-00055
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 00432604600
• Device Lot Number: 62125388
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Date Device Manufactured: 08/31/2012
• 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 Age: 71 YR