MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP REV GLEN BSPLT REAMR; SHOULDER PROSTHESIS

Catalog Number 405807

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No reamer product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided for part 405807.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

It was reported that the reamer is dull.There was no patient injury as a result of the malfunction.Attempts have been made and no additional information is available at the time of this report.

• Brand Name: 25MM COMP REV GLEN BSPLT REAMR
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14164069
• MDR Text Key: 289726078
• Report Number: 0001825034-2022-00936
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1