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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Tissue Damage (2104); Anxiety (2328); Injury (2348); Depression (2361); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Event Date 03/27/2017
Event Type  Injury  
Manufacturer Narrative
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. 510k: this report is for an unknown device/unknown lot. Part and lot number are unknown; udi number is unknown. (b)(4).
 
Event Description
Pinnacle mom litigation records received. Litigation alleges popping, pain, injuries, lack of mobility, emotional distress, anxiety, depression, disability and elevated metal ion levels. However, lab result shows metal ion levels were below 7ppb. It was also stated that the patient was revised to address mechanical complications and bearing surface wear resulting to metallosis. Revision note reported some grayish staining within the trochanter bursa region and some bone type tissue forming between the metal liner and shell. Doi: (b)(6) 2007; dor: (b)(6) 2017; right hip.
 
Event Description
Ppf alleges abductor muscle repair.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
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, IN 19380-0988
6103142063
MDR Report Key8390747
MDR Text Key137837513
Report Number1818910-2019-86452
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
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 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
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 Received04/04/2019
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: 03/05/2019 Patient Sequence Number: 1
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