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

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

The patient is being considered for a revision for unknown reasons at an unknown date.No further information is available at the time of this reporting.

Manufacturer Narrative

The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient was revised to address humeral loosening after 10-15 years in-vivo.No further information is available at this time.

Manufacturer Narrative

Multiple mdrs were filed in association with this event.Please see: 0001825034 - 2019 - 00874.Concomitant medical products: unknown part/lot; glenoid.No device was returned for review, the complaint cannot be confirmed.No device history record review could be completed without part/lot code combination.Without further information regarding the nature of the event; the event cannot be confirmed.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 information is available at the time of this reporting.

• Brand Name: UNKNOWN HUMERAL STEM
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8326172
• MDR Text Key: 135733912
• Report Number: 0001825034-2019-00563
• Device Sequence Number: 1
• Product Code: KWY
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 02/12/2019; 02/26/2019
• Supplement Dates FDA Received: 02/18/2019; 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 64 YR