MAUDE Adverse Event Report: ZIMMER TMT TM GLENOID COMPONENT 52 MM ARTICULAR SURFACE

Model Number N/A

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation, therefore only a device history review was performed.Device history records were reviewed for the glenoid component and no deviations or anomalies were found.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.Due to the litigation process, little detail is available to aid in this investigation at this time.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

Patient¿s legal counsel reported patient underwent right shoulder surgery on (b)(6) 2013.Legal counsel further reports patient underwent a revision procedure on (b)(6) 2017 due to patient allegations of loosening.Patient also reports pain and limited range of motion.This report is based on allegations set forth in plaintiff¿s complaint, and the allegations contained therein are unverified.Tm glenoid is the only tmt design controlled part.

• Brand Name: TM GLENOID COMPONENT 52 MM ARTICULAR SURFACE
• 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: bhairavi patel ; 10 pomeroy road; parsippany, NJ 07054 ; 8622611175
• MDR Report Key: 7358953
• MDR Text Key: 103097323
• Report Number: 3005751028-2018-00024
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 00432605200
• Device Lot Number: 62338786
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2013
• 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: 65 YR