MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ROTATING HINGE KNEE CEMENT SHIELD HINGE SERVICE KIT SIZE D PROSTHESIS, KNEE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hematoma (1884); No Information (3190)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical devices - unknown nexgen femoral component, catalog #: ni, lot #: ni; unknown nexgen articular surface, catalog #: ni, lot #: ni. Report source - foreign: (b)(6). It is unknown at this time whether the product will be returned to zimmer biomet for investigation. 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 patient; please see all reports associated with this event: 0001822565-2019-00058, 0001822565-2019-00060. Investigation incomplete.

Event Description

It is reported that the patient underwent a right knee arthroplasty revision to address unknown complications post-operatively. It is unknown how long each device was implanted or which devices were replaced.

• Brand Name: NEXGEN ROTATING HINGE KNEE CEMENT SHIELD HINGE SERVICE KIT SIZE D
• Type of Device: PROSTHESIS, KNEE
• 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: 8217645
• MDR Text Key: 132091718
• Report Number: 0001822565-2019-00059
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K070978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 00585007514
• Device Lot Number: 62103928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2012
• 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 Treatment Data

Date Received: 01/04/2019 Patient Sequence Number: 1