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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Reaction (2414)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #: 00434903606, poly liner plus 6 mm offset 36 mm diameter, lot # unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital will not return the product.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001822565-2019-05384.Requested but not returned by hospital.

Event Description

It was reported the patient underwent an initial shoulder anthroplasty approximately (2)years ago.Subsequently, the patient has been revised due to disassociation and metalosis.

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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

No further event information available at the time of this report.

• Brand Name: UNKNOWN HUMERAL STEM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9510326
• MDR Text Key: 172619069
• Report Number: 0001822565-2019-05387
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention