MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE; PROSTHESSI KNEE

Model Number N/A

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: nexgen stemmed tibial component, catalog #: 00598003701, lot #: 62053699, nexgen all polyethylene patella, catalog #: 00597206529, lot #: 61914159, nexgen femoral component, catalog #: 00596401452, lot #: 62041497, nexgen taper stem plug, catalog #: 00596009900, lot #: 62100825.Report source: (b)(6).Reported event was confirmed by review of x-rays provided.Review of the x-rays confirms failure (disengagement and proximal migration) of right knee tibial baseplate taper plug.X-rays show similar tibial tray coronal varus malalignment.Tibial component varus malalignment may result in increased contact stresses, accelerated wear and asymmetrical forces on the tibial taper plug.Thus, tibial tray component malalignment is thought to be a risk factor for knee arthroplasty failure, including disengaged tibial baseplate taper plug.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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.

Event Description

It was reported that the patient is experiencing pain caused by the taper plug migrating out of the component.Attempts have been made and no further information has been provided.

• Brand Name: NEXGEN ARTICULAR SURFACE
• Type of Device: PROSTHESSI 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: 7569005
• MDR Text Key: 110069734
• Report Number: 0001822565-2018-03069
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: PK991581
• 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
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 00596003017
• Device Lot Number: 61755364
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR