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

Model Number N/A

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

Patient Problem Death (1802)

Event Date 04/04/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown srs distal stem, unknown srs proximal body, unknown humeral tray, unknown glenoid, unknown glenoid base plate.Dave r shukla, julia lee, devin mangold, robert h cofield, joaquin sanchez-sotelo, and john w sperling,(2018).Reverse shoulder arthroplasty with proximal humeral replacement for the management of massive proximal humeral bone loss.Journal of shoulder and elbow arthroplasty, volume 2: pg.1¿6.Doi: 10.1177/2471549218779845, journals.Sagepub.Com/home/sea.Reported event was unable to be confirmed.Dhr review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018- 05661, 0001825034-2018-05386, 0001825034-2018-05387, 0001825034-2018-05393, 0001825034-2018-05395.

Event Description

It was reported in the journal article that one patient expired due to unknown reasons within two year follow-up.The specific cause of death is not listed, however, there is no indication it is product or procedure related within the article.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Root cause is related to patient condition.Per the author, "none of the complications or failures were due to problems inherent with the implants.They were due to patient co-morbidities and effects of having multiple prior procedures." 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 in the journal article that one patient expired due to unknown reasons within two year follow-up.The specific cause of death is not listed, however, there is no indication it is product or procedure related within the article.No additional information is available at this time.

• Brand Name: UNKNOWN HUMERAL BEARING
• 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: 7742535
• MDR Text Key: 115801439
• Report Number: 0001825034-2018-05392
• Device Sequence Number: 1
• Product Code: KWS
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

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: Health Professional
• Device Model 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: 07/06/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/29/2018
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death