MAUDE Adverse Event Report: ZIMMER, INC. FEMORAL COMPONENT POROUS SIZE D LEFT; PROSTHESIS, KNEE

Model Number N/A

Device Problems Flaked (1246); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 12/02/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Articular surface 9mm height catalog 00597003009 lot 6216766.

Event Description

Patient underwent a left knee revision procedure approximately four years post implantation due to femoral loosening.It was noted that the porous coating was peeling off of the femoral component.The femoral component and articulating surface were removed and replaced.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.

Manufacturer Narrative

(b)(4).The following report is submitted to relay additional information.The reported event is confirmed.The visual inspection of the returned articular surface found wear on the left lip and the middle of the implant.Metallic particles were found embedded in the articular surface.The dovetail was found flared out.Visual inspection of the porous femoral component found foreign material on the porous material.Wear was found on the anterior side of the implant.A portion of the porous material on the right superior side is missing.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.A complaint history review was performed.Review of the complaint history determined that no further action is required.X-ray review identified radiolucencies at the femoral component/bone interface indicating loosening.X-ray review also states that the distal femur exhibits bony sclerosis.A definitive root cause cannot be determined with the information provided no corrective actions needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: sem analysis of the femoral component identified a possible weld spot in the region missing the fiber metal.Material analysis of the debris embedded in the articular surface confirmed it was cocrmo, which is consistent with the fiber metal material.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.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: FEMORAL COMPONENT POROUS SIZE D LEFT
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6218404
• MDR Text Key: 63731183
• Report Number: 0001822565-2017-00014
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK031061
• 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,Followup,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00595201401
• Device Lot Number: 11008142
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2012
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR