MAUDE Adverse Event Report: ZIMMER INC PERSONA CPS ARTICULAR SURFACE SHIM; MBH

Catalog Number 42527900404

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the persona tasp cps shim found that one of the ball bearings and springs fell out of the shim construct.The ball bearing and spring that disassembled from the shim construct were also returned.The device is used for treatment.A product history search identified no other complaints for this part and lot combination.This complaint was determined to be related to a previously identified issue.A previous investigation has identified that ultrasonic cleaning may cause ejecting of the spring and ball from the persona tasp cps shim and that a user need of the device to be able to withstand ultrasonic cleaning was not identified during development.This issue has been reported to the fda under (b)(4).

Event Description

It is reported that the articular surface provisional shim was found to be missing a ball bearing.

• Brand Name: PERSONA CPS ARTICULAR SURFACE SHIM
• Type of Device: MBH
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5150110
• MDR Text Key: 28577775
• Report Number: 1822565-2015-02123
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42527900404
• Device Lot Number: 62518293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1