MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has not indicated whether the product will be returned to zimmer biomet for investigation or not.Once this information is obtained 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.

Event Description

It was reported that the item dropped during cleaning and impact portion broke.No additional information is available.

Event Description

Upon reassessment of the reported event it was determined that the instrument malfunction is no longer reportable.Hence the initial report submitted needs to be voided as it was reported in error.

Manufacturer Narrative

Upon reassessment of the reported event it was determined that the instrument malfunction is no longer reportable.Hence the initial report submitted needs to be voided as it was reported in error.

• Brand Name: 25MM COMP RVS GLEN TRAY IMPTR
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9646844
• MDR Text Key: 199246193
• Report Number: 0001825034-2020-00419
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405809
• Device Lot Number: 2596027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1