MAUDE Adverse Event Report: ZIMMER, INC. SEGMENTAL PROXIMAL TIBIA ATTACHMENT KIT; KNEE PROSTHESIS

Catalog Number 00585000011

Device Problems Out-Of-Box Failure (2311); Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that when opening the segmental proximal tibia attachment kit during a segmental surgery, there were only two claws marked with squares.It was expected that one claw would be marked with a triangle.The surgeon decided to use the claws as there was no other available option.

Manufacturer Narrative

No devices or photos were received, therefore the alleged discrepancy cannot be confirmed.The device history records for the 00-5850-000-11, lot # 62467977 were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.This device was used for treatment.A product history search identified no other complaints for the part and lot combination of the proxial tibial tissue attachment kit.A definitive root cause cannot be determined with the information available.This complaint was determined not to be a new confirmed quality or manufacturing issue.Complaints are monitored through monthly meetings ((b)(4)) in order to identify potential adverse trends.

Manufacturer Narrative

A summary of the investigation has been sent to the complainant.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: SEGMENTAL PROXIMAL TIBIA ATTACHMENT KIT
• Type of Device: KNEE PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6051989
• MDR Text Key: 58209940
• Report Number: 0001822565-2016-03826
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PK110940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 00585000011
• Device Lot Number: 62467977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 80