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

Model Number N/A

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

Patient Problem Death (1802)

Event Date 07/18/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 03930, 0001825034 - 2018 - 03939, 0001825034 - 2018 - 03941, 0001825034 - 2018 - 03969.Patient died.

Event Description

It was reported that patient underwent a reverse shoulder arthroplasty.Subsequently, after four (4) years post initial surgery, the patient died due to unknown reasons.There is no indication that the device caused or contributed to the death.There were no noted complications at patient's last follow-up one (1) year post-operatively.No further information is available.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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 was reported that patient underwent a reverse shoulder arthroplasty.Subsequently, after four (4) years post initial surgery, the patient died due to unknown reasons.There is no indication that the device caused or contributed to the death.There were no noted complications at patient's last follow-up one (1) year post-operatively.No further information is available.

• Brand Name: COMPREHENSIVE REVERSE GLENOSPHERE STANDARD
• 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: 7594556
• MDR Text Key: 110846360
• Report Number: 0001825034-2018-03942
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080642
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 115310
• Device Lot Number: 585640
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2011
• 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): Death
• Patient Age: 72 YR
• Patient Weight: 75