MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 09/02/2013

Event Type  Death  

Manufacturer Narrative

(b)(6).Customer has indicated that the product will not be returned [location unknown] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03318, 0001825034-2017-07301, 0001825034-2017-07302, 0001825034-2017-07303, 0001825034-2017-07304, 0001825034-2017-07305, 0001825034-2017-07306, 0001825034-2017-07307, 0001825034-2017-07308, 0001825034-2017-07309, 0001825034-2017-07310, 0001825034-2017-07311, 0001825034-2017-07312, 0001825034-2017-07313, 0001825034-2017-07314.

Event Description

It was reported that the clinical patient underwent a total humeral replacement and later developed infection.Several debridements were performed on unknown dates.The patient was later reported as deceased due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer and no product was returned.Dhr and complaint history could not be reviewed due to the lack of information received.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN COMPREHENSIVE REVERSE GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6887874
• MDR Text Key: 87154579
• Report Number: 0001825034-2017-07308
• Device Sequence Number: 1
• Product Code: MJT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2017
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 61 YR