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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD

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DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP FEMORAL HEAD Back to Search Results
Catalog Number UNK HIP FEMORAL HEAD
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104); Distress (2329); Injury (2348); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)
Event Date 01/16/2017
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.
 
Event Description
Asr litigation and medical records received. Litigation alleges injuries. After review of medical records for mdr reportability, patient was revised to address pain. Revision notes reported of stained black and consistent with the diagnosis of metalosis. The metallic head was removed from the depuy summit stem and an obvious metal reaction present at the trunnion. There was lytic destruction of the acetabulum beneath the component. This was not severe as was encountered on the left side, but this right hip show a 1 x 1. 5 mm area of cystic erosion in the superoanterior acetabulum. Upon inserting the acetabular component, a nondisplaced fracture was noted to develop in the bone of the posterior column. It was also stated that patient had an asr components implanted on (b)(6) 2007 and (b)(6) 2007. However, there are no primary surgery notes provided to confirm the correct doi for each affected side. Should there be new information, this complaint will be updated. Doi: unknown; dor: (b)(6) 2017; right hip. This was linked to (b)(4) for the left hip.
 
Manufacturer Narrative
(b)(4). Investigation summary no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #
==
> pc-(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
Asr litigation record received. In addition to what were previously alleged, litigation alleges high metal ions, and emotional distress. Doi: (b)(6)2007.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided. On 11/27/2018: additional information received. 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 will be filed as appropriate.
 
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Brand NameUNKNOWN HIP FEMORAL HEAD
Type of DeviceHIP FEMORAL HEAD
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key7490149
MDR Text Key107457152
Report Number1818910-2018-58883
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/19/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1749/1816-2011

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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