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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE UNK KNEE FEMORAL SLEEVE

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DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE UNK KNEE FEMORAL SLEEVE Back to Search Results
Catalog Number UNK KNEE FEMORAL SLEEVE
Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Event Date 10/08/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Dimensions of the above implant required excessive reaming, burring and shaping of the distal femur to accommodate the implant. More than i expected for a custom implant that was measured on info from ct scan.
 
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Brand NameUNKNOWN KNEE FEMORAL SLEEVE
Type of DeviceUNK KNEE FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9343694
MDR Text Key187510011
Report Number1818910-2019-117056
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK KNEE FEMORAL SLEEVE
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
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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