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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problem Biocompatibility (2886)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Anxiety (2328); Discomfort (2330); Test Result (2695); No Code Available (3191)
Event Date 02/18/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device was used for treatment, not diagnosis. (b)(4).
 
Event Description
The patient had a right tha performed (b)(6) 2008 using trilock stem and asr cup. This surgeon did a work-up he said, and found elevated blood serum metal ion levels. He wouldn't share with me what those levels were. But he did tell me that the patient wasn't experiencing any pain at all. In fact he said that the patient told him his left hip, which is still a native hip, hurt a lot worse than his rt. The surgeon told me he felt that he needed to revise because of the blood test results. During the surgery, the surgeon told me that the hip and tissues looked normal. After removing the asr 51 head and -1 sleeve, the surgeon said around the trunnion that there was trunnionosis. When he put the old asr on the table, i could visually see some of the black marks he was referring to. The surgeon chose to use a s&n 51/28 dual mobility head and a depuy ceramic ts 28 +5 head. The surgeon put in the real implants and was very happy with the stability, leg length and offset. He closed the patient up.
 
Manufacturer Narrative
Udi: (b)(4).
 
Event Description
Litigation records allege pain, stiffness, discomfort, weakness, limited mobility, and anxiety.
 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM
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, PA 19380
6103142063
MDR Report Key8416355
MDR Text Key138656833
Report Number1818910-2019-87151
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
Type of Report Initial,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL STEM
Device Lot NumberUNKNOWN
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 Received04/30/2019
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: 03/13/2019 Patient Sequence Number: 1
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