MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COMPREHENSIVE HUMERAL STEM; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).Journal article reference: nelson, clay g.; brolin, tyler j.; ford, marcus c.; smith, richard a.; azar, frederick m.; throckmorton, thomas w.(2018).Five-year minimum clinical and radiographic outcomes of total shoulder arthroplasty using a hybrid glenoid component with a central porous titanium post.Journal of shoulder and elbow surgery, 1058-2746/$, pages 1-6.Https://doi.Org/10.1016/j.Jse.2018.01.012.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as patient died.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03362, 0001825034-2018-03364, 0001825034-2018-03365.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

It has been reported in a journal article that six (6) patients who underwent total shoulder arthroplasty's, died on unknown dates after follow-up due to unknown reasons.There was no indication that the cause of death was related to the procedure.It was further relayed that the deaths were not related to the implants.No further information is available.

• Brand Name: UNKNOWN COMPREHENSIVE HUMERAL STEM
• 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: 7514387
• MDR Text Key: 108262735
• Report Number: 0001825034-2018-03363
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• 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
• Patient Sequence Number: 1
• Treatment: UNKNOWN GLENOID; UNKNOWN HUMERAL HEAD; UNKNOWN REGENEREX POST
• Patient Outcome(s): Death