MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEMENT SHIELD HINGE SERVICE KIT SIZE B; PROSTHESIS, KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00585002012 - articular surface - 63530803.00585204035 - stem collar - 64073497.00585001296 - polyethylene insert - 64058793.00597206529 - all poly patella - 64163932.00585004202 - femoral component - 63917928.00585205015 - fluted stem extension - 64069897.00545001731 - femoral diaphyseal cone - 63768449.00598304027 - screw - 64057985.00588000302 - tibial component - 63548490.00545001341 - tibial cone - 64204230.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient underwent a zss revision procedure for unknown reasons.During the revision the service parts were removed.Due to the wrong parts in the box the old service parts were put back into patient.Attempts have been made and no further information has been provided.

Event Description

The patient was revised due to the patella tracking laterally.It was noted the position of the femur was changed, as well as tissue debridement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: a1; b4; b5; g4; g7; h1; h2.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00529.

Event Description

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

Manufacturer Narrative

Upon receiving additional information of the reported event, it was determined to be not reportable.The initial report should be voided.

• Brand Name: CEMENT SHIELD HINGE SERVICE KIT SIZE B
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10941760
• MDR Text Key: 219491224
• Report Number: 0001822565-2020-03992
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 00889024196339
• UDI-Public: (01)00889024196339(17)220630(10)62739301
• Combination Product (y/n): N
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00585007512
• Device Lot Number: 62739301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention