MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET MODULAR HUMERAL HEAD GREEN; PROSTHESIS, SHOULDER

Catalog Number 00430205627

Device Problem Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: glenoid component keeled 56 mm diameter articular surface used with blue (52 mm) instruments, cat# 00430005256, lot# 63425483.Humeral stem 18 mm stem diameter 130 mm stem length, cat# 00434901813, lot# 63102455.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 01650.

Event Description

It was reported that a patient underwent a right initial total shoulder procedure.Subsequently, the patient underwent a revision from a total to a reverse due to wear approximately 16 months later.No further information is known.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

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

• Brand Name: OFFSET MODULAR HUMERAL HEAD GREEN
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10032601
• MDR Text Key: 190164454
• Report Number: 0001822565-2020-01649
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K110791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 00430205627
• Device Lot Number: 61867542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention