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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER MODULAR M/L FEMORAL TAPER STEM WITH KENECTIV TECHNOLOGY HIP PROSTHESIS

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ZIMMER, INC. ZIMMER MODULAR M/L FEMORAL TAPER STEM WITH KENECTIV TECHNOLOGY HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Material Discolored
Event Date 10/18/2016
Event Type  Injury  
Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.

 
Event Description

It was reported the inner plastic bag of the product turned black. The product was used by the surgeon.

 
Manufacturer Narrative

Upon further review it was found that this malfunction did not and has not been previously reported as causing or contributing to an adverse event. Therefore, the initial report was filed in error and should be voided. 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 NameZIMMER MODULAR M/L FEMORAL TAPER STEM WITH KENECTIV TECHNOLOGY
Type of DeviceHIP PROSTHESIS
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
kathleen smith
p.o. box 708
warsaw , IN 46580
8006136131
MDR Report Key6110665
Report Number0001822565-2016-04262
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/17/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00771301600
Device LOT Number62521427
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 Received03/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 11/17/2016 Patient Sequence Number: 1
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