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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Revision of the right hip implant after pain and difficulty in walking. During the revision it was detected abundant reaction tissue with joint effusion blood serum from suspected serum/pseudotumor reaction. The histological examination showed an intense inflammatory reaction from a foreign body to a predominant macrophage component of the bone and periosteal soft tissues, conditioning aseptic osteolysis. Doi: (b)(6) 2007; dor: (b)(6) 2019; right hip.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11004473
MDR Text Key221501843
Report Number1818910-2020-26889
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
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 Received12/23/2020
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

Patient Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
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