MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL; KNEE PROVISIONAL

Catalog Number 42527400810

Device Problems Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It has been reported that the provisional was found fractured.Not all of the pieces were found and their location is unknown.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unavailable at the time of initial follow up.Visual examination found that the returned tibial articular surface provisional (tasp) has a fracture on the lateral side of the post, the fractured piece was not returned for further evaluation.The complaint is considered confirmed as the returned tasp is fractured.The likely condition of the part when it left zimmer biomet control is considered conforming based on the manufacturing review and returned product.These devices were used for treatment.A notification was sent to the field on august 7th, 2014 to provide additional clarifications relating to the instructions for use of the tasp construct for all persona users on file at the time of the field notice.Ps tasp top components and standard (non-cps) tasp bottom components have been modified to prevent fracture.The fractured tasp component in this complaint was manufactured before the design modification.The root cause is considered to be a previously addressed design issue.

• Brand Name: PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL
• Type of Device: KNEE PROVISIONAL
• 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: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5899840
• MDR Text Key: 52854225
• Report Number: 0001822565-2016-02965
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42527400810
• Device Lot Number: 62104441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2579-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other