MAUDE Adverse Event Report: ZIMMER TMT TRABECULAR METAL GLENOID COMPONENT 52 MM; TM GLENOID

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the implant's manufacturing record indicates that it was manufactured to specification.Based on the information available, the root cause of the event cannot be determined.Should additional information be obtained to further this investigation, this report shall be updated.

Event Description

It was reported that on follow-up yearly x-ray it was noted that there appeared to be radiopaque particles in and around the joint space.The tm glenoid component appears well fixed and supported in surrounding bone.The surgeon is considering a revision due to appearance of the particles in and around joint space.The patient is asymptomatic.Note that this patient event was initially reported through zimmer biomet (b)(4) on (b)(6) 2016 through report 1822565-2016-00084.Zimmer biomet (b)(4) notified zimmer biomet (b)(4) that the product was manufactured at (b)(4) when they received supplemental information on feb.1, 2016 that indicated the part and lot identification.

Manufacturer Narrative

(b)(6) year old male patient received a right side tsa on (b)(6) 2008.The tm glenoid and prosthetic humeral head appeared to be well-aligned/tm glenoid potentially in slight retroversion at one year post-op.At two years post-op, tsa is unchanged from year one.At five years post-op, radiology reported calcifications seen on x-ray but the hardware was intact and aligned while this investigation suspected both a radiolucent line likely located at the junction where the cruciate keel joined the base plate as well as a radiopaque particle located superior to the tm glenoid.Patient was asymptomatic at the time when the per was submitted; however, the surgeon at that time had suspected that the metal had separated from the poly.The patient was eventually revised on (b)(6) 2016 when it was found that the tm glenoid had failed/fractured at the junction where the cruciate keel joined the base plate.However, based upon the information available for this engineering investigation, a definitive cause for the tm glenoid failure could not be determined.

Event Description

Particles seen on radiograph - unknown origin - no revision.

• Brand Name: TRABECULAR METAL GLENOID COMPONENT 52 MM
• Type of Device: TM GLENOID
• 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: 5408180
• MDR Text Key: 37723252
• Report Number: 3005751028-2016-00002
• 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: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: N/A
• Device Catalogue Number: 00432605200
• Device Lot Number: 61242230
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2009
• 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): Other