MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN CR-FLEX CRUCIATE RETAINING POROUS FEMORAL COMPONENT; KNEE PROSTHESIS

Catalog Number 00575201706

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that when the knee implant was opened, the plastic casings were cracked, compromising sterility and making the device unusable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.No product was returned; from the evaluation of received photos, it was determined that the one cavity was cracked, it is unknown whether other cavity cracked or not and it is also unknown whether it's inner or outer.Device history record 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 CR-FLEX CRUCIATE RETAINING POROUS FEMORAL COMPONENT
• Type of Device: KNEE PROSTHESIS
• 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: 6078629
• MDR Text Key: 59221000
• Report Number: 0001822565-2016-03829
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PK072619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00575201706
• Device Lot Number: 62801765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• 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