MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID 40MM, 46MM ART

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

Investigation in process.Device not returned yet.

Event Description

It was reported that the patient complained of pain.The tm glenoid was removed and appeared loose.Significant wear on the glenoid surface.

Manufacturer Narrative

The tm glenoid was manufactured, inspected and packaged within established process specifications and was found to be compatible with the humeral head that was implanted.The tm glenoid was implanted for approx.5 years ((b)(6) 2011-(b)(6) 2016).The explanted device was not returned nor was immediate post-op x-rays provided so the initial position or alignment of the device could not be determined.The package insert (pi-025), which is shipped with each implant, specifically lists loosening as an adverse effect.Failure of the tm glenoid was not confirmed by this investigation.This investigation is considered closed at this time.Should additional information become available, this investigation may be re-opened.

Event Description

Revision due to pain, loosening, and wear.

• Brand Name: TM GLENOID 40MM, 46MM ART
• 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: 5890322
• MDR Text Key: 52573173
• Report Number: 3005751028-2016-00063
• 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: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00-4326-040-46
• Device Lot Number: 61826822
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2011
• 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: 66 YR