MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN TIBIAL BLOCK AND SCREWS; PROSTHESIS KNEE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: nexgen lcck articular surface catalog # 00599403210 lot # 62841440; nexgen lcck femoral component catalog # 00599401692 lot # 62941772; nexgen all poly patella catalog # 00597206529 lot # 62913325; nexgen tibial component catalog # 00598003701 lot # 63064339; nexgen pre fem augments catalog # 00-5990-036-01 lot # 62998830; nexgen augments distal only femoral catalog # 00599003621 lot # 62591559; nexgen stem extension catalog # 00598801012 lot # 62937550; nexgen distal femoral augments catalog # 00599003620 lot # 62998879; nexgen stems extension catalog # 00598801010 lot # 62860982; nexgen tibial block and screws catalog # 00598800327 lot # 62641746.Report source: (b)(6).Customer has indicated that the product will not be returned because product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565-2018-01323, 0001822565-2018-01465, 0002648920-2018-00186, 0002648920-2018-00187, 0002648920-2018-00188, 0001822565-2018-01476, 0002648920-2018-00189, 0001822565-2018-01481, 0002648920-2018-00190, 0001822565-2018-01484.

Event Description

It was reported that the patient underwent a first revision knee arthroplasty due to an unknown reason.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: NEXGEN TIBIAL BLOCK AND SCREWS
• 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: 7335364
• MDR Text Key: 102257619
• Report Number: 0001822565-2018-01483
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK862632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598800327
• Device Lot Number: 62925302
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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 Outcome(s): Hospitalization; Required Intervention