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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 Problem Naturally Worn (2988)
Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Osteolysis (2377); No Code Available (3191)
Event Date 03/27/2019
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
Patient experienced pain. After review of medical record, patient was revised to address right total hip arthroplasty mechanical failure. Favor wear induced synovitis was also stated as clinical findings and aseptic bursitis. Revision notes stated that the osteolytic lesion within the trochanter was easily identifiable as extensive amount of loss of bone in the area. Metallosis was noted and removed all the non viable gray and black tissue from the lining of the joint. The cyst was decompressed which involved of 50 cc of gray materials. Cup and head were removed. Implanted products were not known if depuy products. Doi: unknown. 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, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10026239
MDR Text Key189975229
Report Number1818910-2020-11694
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 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received05/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2020 Patient Sequence Number: 1
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