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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Pain (1994); Injury (2348); Osteolysis (2377); No Code Available (3191)
Event Date 12/10/2018
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Us fda mdr determination: there were no reported product problems with the cup. It is reasonable to conclude that the reported patient harms are attributed to the stem corrosion and the pseudotumor which is associated with the articulating surface. (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
Medical records received. After review of medical records, the patient was revised to address a failed right total hip arthroplasty with pain, pseudotumor and increased levels of cobalt and chrome. X-rays show loosening on the calcar around the lesser trochanter. Intraoperatively there was approximately 50 cc yellowish milky fluid, osteolysis, spot welding on the proximal femur, bone loss, oxidation and blackening on the trunnion. The surgeon performed an extended trochanteric osteotomy and as the stem was being removed, the proximal calcar fractured. There was a concern that there might be an infection so the surgeon went in an implanted an antibiotic spacer. Doi: (b)(6) 2011. Dor: (b)(6) 2018, (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 Key9779935
MDR Text Key181787385
Report Number1818910-2020-06648
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
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: 03/03/2020 Patient Sequence Number: 1
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