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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PS-CPS FEMORAL PROVISIONAL LEFT SIZE 7 KNEE INSTRUMENTS

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ZIMMER BIOMET, INC. PS-CPS FEMORAL PROVISIONAL LEFT SIZE 7 KNEE INSTRUMENTS Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
Event Date 05/08/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Complaint sample was evaluated and the reported event was confirmed. Sem / eds analysis of the debris found on the instruments was performed and observed that the various effected areas were filled with debris which predominantly showed oxides and some areas showed chlorine. Dhr was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action is required as no were trends identified. The root cause is attributed to a maintenance due to following reason. All the metallic instruments contained in the trays show water marks. Some of the chemical elements (ca, s, o) do not come from the instruments themselves, but could come from caso4 contained in hard water. The black residue is ¿uniformly¿ spread on each and all the instruments, which is only possible through contact with air and water. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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.

 
Event Description

It was reported that during the initial operating room setup the nurse was handling the persona femoral provisionals and noticed black residue on her gloves. On the inside of the femoral provisionals black debris was noticed in all left and right femoral provisionals. All 5 sets were examined and all had the same black debris.

 
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Brand NamePS-CPS FEMORAL PROVISIONAL LEFT SIZE 7
Type of DeviceKNEE INSTRUMENTS
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7349565
MDR Text Key102850280
Report Number0001822565-2018-01600
Device Sequence Number1
Product Code MBH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberPK123459
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number42504706201
Device LOT Number63322134
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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