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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS, INC. 1818910  UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Corroded (1131)
Patient Problems Inflammation (1932); Discomfort (2330); Osteolysis (2377)
Event Date 08/03/2017
Event Type  Injury  
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
Significant high volume synovitis and reactive inflammatory fluid volume. The synovitis was consistent with the hyperplastic response having an orange-tinged coloring and the fluid volume was dark brown fluid. Exploration of the hip revealed significant cortical lysis and lytic changes superior to the shell. There was lytic changes and cortical lysis that extended down along the posterior femoral wall extending into the lesser trochanter and corrosion below the metal head and neck. Doi: (b)(6) 2006; dor: (b)(6) 2017; (right hip).
 
Manufacturer Narrative
(b)(4). No device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key8273210
MDR Text Key133942050
Report Number1818910-2019-82064
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL HEAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
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

Patient Treatment Data
Date Received: 01/24/2019 Patient Sequence Number: 1
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