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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ENDURANCE SZ 4 STD OFFSET MISCELLANEOUS HIP STEM : HIP FEMORAL STEM

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DEPUY ORTHOPAEDICS INC US ENDURANCE SZ 4 STD OFFSET MISCELLANEOUS HIP STEM : HIP FEMORAL STEM Back to Search Results
Catalog Number 152104000
Device Problem Loss of Osseointegration (2408)
Patient Problems Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative
(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
Left hip revision - original surgery (b)(6) 1998. Endurance stem was loose and liner was eccentric. No surgical delay.
 
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Brand NameENDURANCE SZ 4 STD OFFSET
Type of DeviceMISCELLANEOUS HIP STEM : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9813415
MDR Text Key183089150
Report Number1818910-2020-07357
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,health
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number152104000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/1997
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/10/2020 Patient Sequence Number: 1
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