MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID 52MM, 46MM ART

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Unspecified Infection (1930)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

Investigation in process.

Event Description

It was reported that the patient was presented with an infection.X-rays previous to surgery suggested implant had failed.At surgery it was found poly from glenoid implant had loosened from tm base.It appeared that tm posts were still insitu along with stem and head.Washout performed poly removed.More x-rays to be attended.Patient will require more surgery according to dr (b)(6).

Manufacturer Narrative

The device was manufactured, inspected and packaged within established process specifications with no anomalies found.The mating humeral head was found to be compatible with the tm glenoid that was implanted.The tm glenoid (keel) did not appear as expected during the engineering review of the x-rays that were provided, rather the tm keel appeared fractured with the disc portion of the tm keel displaced inferiorly.The disc portion of the tm keel is attached to and integral with the poly articular surface of the overall tm glenoid and is therefore an indicator of the poly articular surface location since poly is radiolucent on x-ray.An engineering review of the photographs that were provided for this investigation confirms that the poly articular surface of the tm glenoid had fractured and separated from the tm keel.Tm particulate, albeit unconfirmed since the device was not returned for analysis, is suspected to be embedded in the poly articulating surface.It appears that the tm glenoid was implanted cementless which is an approved method outside of the usa, but again the explanted device was discarded by the hospital and not available for evaluation.Patient is a (b)(6) male, clinically obese but no activity level was reported.No report of a fall was communicated via email follow-up.It was noted however that the patient became non-compliant with follow-up visits with the surgeon.The root cause for the failure of the tm glenoid has not been determined; however, patient weight and non-compliance with follow-up visits with the surgeon may have been contributing factors.This investigation is considered closed at this time; however, should additional information become available, this investigation can be re-opened.

• Brand Name: TM GLENOID 52MM, 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: 6178792
• MDR Text Key: 62545027
• Report Number: 3005751028-2016-00085
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 00-4326-052-46
• Device Lot Number: 62352790
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2013
• 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: 64 YR