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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. PROPHECY PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number PROPINB
Device Problem Use of Device Problem
Event Date 07/30/2018
Event Type  Malfunction  
Manufacturer Narrative

The device has been returned to the manufacturer for evaluation. Analysis results are not available at the time of this report. A follow-up report will be sent when the analysis is complete.

 
Event Description

Allegedly, the stem alignment guide did not fit. The whole guide seemed to sit anterior off the tibia bone approximately 1 cm. The guide appeared to be pushed posterior as far as the surgeon could get it and no surface match was achieved. The surgeon checked the cuts and made sure there was no bone or soft tissue impingement numerous times with no success. The surgeon then switched over to the foot holder for drilling and reaming. Surgery was delayed about 90 minutes between "recalibrating foothold ml and ap rods and dropping and reinflating the tq".

 
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Brand NamePROPHECY
Type of DevicePROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis , TN 38117
9014516318
MDR Report Key7819737
Report Number1043534-2018-00089
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date12/26/2018
Device MODEL NumberPROPINB
Device LOT Number1633653
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/30/2018
Event Location Hospital
Date Manufacturer Received07/30/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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