MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN NEXGEN LPS FLEX TIBIAL COMPONENT; PROSTHESIS, KNEE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign: (b)(6).Literature: huitema, g.C., de vries, l., verboom, t.W., spekenbrink-spooren, a., & steens, j.(2022).Patella related problems as common reason for revision of nexgen ps® total knee arthroplasty without patella resurfacing: an analysis of 5911 primary total knee arthroplasties registered in the (b)(6) register.The knee, 34, 217¿222.Https://doi.Org/10.1016/j.Knee.2021.12.008.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01463, 0001822565-2022-01465.

Event Description

A journal article was retrieved from the knee (2022) that reported a retrospective study from the (b)(6) that accumulated data from the dutch arthroplasty register (lroi).The purpose of the study was to investigate if there was a difference in revision rate and reason for revision within 8 years after single brand primary cemented tka with or without patella resurfacing, using data from the (b)(6) register.The study reported 50 patients were revised due to malalignment.Due diligence is complete as it was reported no further information is available.As no additional information or product has been received, we are unable to provide further information.

• Brand Name: UNKNOWN NEXGEN LPS FLEX TIBIAL COMPONENT
• 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: 14428863
• MDR Text Key: 291943085
• Report Number: 0001822565-2022-01464
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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