MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOSPHERE 36 MM DIAMETER; SHOULDER, PROSTHESIS

Catalog Number 00434903611

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: poly liner plus 0 mm offset 36 mm diameter cat: 00434903600, lot: 62433842.Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.Product not returned.

Event Description

It was reported that the patient underwent a revision due to glenosphere disassociation.

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Reported event was confirmed by review of radiographs and medical records.Radiographs identified glenosphere dissociation without dislocation.Medical records noted signs of osteolysis and scapular notching.Review of the device history records identified no related deviations or anomalies during manufacturing.Root cause was unable to be determined.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.

• Brand Name: GLENOSPHERE 36 MM DIAMETER
• Type of Device: SHOULDER, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10443170
• MDR Text Key: 204042836
• Report Number: 0001822565-2020-03015
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 00434903611
• Device Lot Number: 62368151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 83