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U.S. Department of Health and Human Services

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

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ZIMMER INC PERSONA CPS ARTICULAR SURFACE SHIM MBH Back to Search Results
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.

 
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Brand NamePERSONA CPS ARTICULAR SURFACE SHIM
Type of DeviceMBH
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 Key5150110
MDR Text Key28577775
Report Number1822565-2015-02123
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received10/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number42527900404
Device LOT Number62518293
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/08/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberZ-1052-2015

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