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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HPSII HIP SIZE 3 STD OTHER PRODUCTS

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DEPUY ORTHOPAEDICS INC US HPSII HIP SIZE 3 STD OTHER PRODUCTS Back to Search Results
Catalog Number 154303000
Device Problem Loss of Osseointegration (2408)
Patient Problems Adhesion(s) (1695); Erosion (1750); Hypersensitivity/Allergic reaction (1907); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 02/07/2008
Event Type  Injury  
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
(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Pcf and medical records received. After review of medical records patient was revised to addressed loose right total hip arthroplasty. Operative notes indicated a large granulomatous type mass infiltrated with debris particles from the hip joint. This caused all the tissue to be scarred together in 1 large mass. The stem was removed without difficulty as it was entirely loose with erosion of the calcar. Only the stem and head were removed. Doi: (b)(6) 2004; dor: (b)(6) 2008 right hip; dor: (b)(6) 2009 (liner). On (b)(6) 2009, patient was revised to address dislocation. Only the liner was depuy and this was revised.
 
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Brand NameHPSII HIP SIZE 3 STD
Type of DeviceOTHER PRODUCTS
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 Key9672188
MDR Text Key184579551
Report Number1818910-2020-04006
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number154303000
Device Lot NumberX91FM1000
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 Received03/12/2020
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: 02/05/2020 Patient Sequence Number: 1
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