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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Corroded (1131); Degraded (1153)
Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Injury (2348); Limited Mobility Of The Implanted Joint (2671)
Event Date 07/19/2016
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
Pfs alleges injuries, pain, muscle spasm, walking difficulty,sleep disturbance, pseudotumors, metallosis and itching around scar tissue. After review of medical records, the patient was revised to address metallosis and pseudotumor resulting to pain. Operative finding reported large pseudotumor and pseudocapsule, a large amount of metal stain fluid present, pseudotumor was dissected, also had a large amount of metal staining around greater trochanter associated with synovitis and bursitis, scar tissue were debrided, some heterotropic bone proximal to the acetabular component, and there was a large amount of metal debris around the taper. There was also corrosion on the femoral head and trunnion. However, trunnion was intact and was not revised. Lab result shows metal ion levels were below 7ppb. Doi: (b)(6) 2008; dor: (b)(6) 2016: left hip.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary
==
> 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.
 
Manufacturer Narrative
Product complaint # (b)(4).
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8451169
MDR Text Key139807320
Report Number1818910-2019-88418
Device Sequence Number1
Product Code KWA
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,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
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 Received01/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/26/2019 Patient Sequence Number: 1
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