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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEUCE FEM OXZR SZ 4 LT; PROSTHSIS, KN PATLLOFMOROTIBIAL, PRTIL, SMI-CNSTRIND, CMNTD, POLYMR/MTL/POLYMR
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SMITH & NEPHEW, INC. DEUCE FEM OXZR SZ 4 LT; PROSTHSIS, KN PATLLOFMOROTIBIAL, PRTIL, SMI-CNSTRIND, CMNTD, POLYMR/MTL/POLYMR Back to Search Results
Catalog Number 71422204
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Date 08/13/2019
Event Type  Injury  
Event Description
It was reported that a deuce was implanted in 2008.In surgery found fx tibial tray in 2 pieces.Poly, femoral and tibial component were completely removed and primary legion knee was implanted.
 
Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
DEUCE FEM OXZR SZ 4 LT
Type of Device
PROSTHSIS, KN PATLLOFMOROTIBIAL, PRTIL, SMI-CNSTRIND, CMNTD, POLYMR/MTL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8981112
MDR Text Key157096644
Report Number1020279-2019-03324
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
PMA/PMN Number
K052265
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number71422204
Device Lot Number07MM09320
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/13/2019
Initial Date FDA Received09/10/2019
Supplement Dates Manufacturer Received08/13/2019
Supplement Dates FDA Received11/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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