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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN PATELLA REAMER WITH PILOT DRILL 38 PROSTHESIS, KNEE INSTRUMENT

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ZIMMER, INC. NEXGEN PATELLA REAMER WITH PILOT DRILL 38 PROSTHESIS, KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problem Insufficient Information
Event Type  Injury  
Manufacturer Narrative

(b)(4). The complaint device will be returned, but the device investigation has not yet been completed. Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.

 
Event Description

It was reported that a patient underwent an initial knee procedure on an unknown date. The patella reaming blade slipped off and patient received injury due to malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.

 
Manufacturer Narrative

The follow-up report is being submitted to relay additional information. 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 also reported that a patient underwent an initial knee procedure on an unknown date. The patella reaming blade slipped off which resulted in increased reaming and thinned bone. No additional patient consequences were reported.

 
Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. The device had approximately 15 years of field life with unknown frequency of usage. The root cause can be considered to be wear due to normal usage. 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.

 
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Brand NameNEXGEN PATELLA REAMER WITH PILOT DRILL 38
Type of DevicePROSTHESIS, KNEE INSTRUMENT
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 Key6859181
Report Number0001822565-2017-06312
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00597907738
Device LOT Number56076600
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/19/2002
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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