MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

The lot number of the implant was not provided, therefore no manufacturing history was reviewed.Per the report the patient was revised due to the device's bearing surface being worn.The device was implant approximately 8 years.No root cause could be determined.Should additional information be obtained, this complaint will reopened.Destroyed when removed.

Event Description

It was reported that the patient underwent initial surgery on (b)(6) 2009.Subsequently he underwent revision on (b)(6) 2017 for pain due to failed worn polyethylene.

• Brand Name: TM GLENOID
• 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: 7074688
• MDR Text Key: 93455907
• Report Number: 3005751028-2017-02745
• 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
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 00432605200
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR