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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/03/2018
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. (b)(4).
 
Event Description
The patient was revised to address pain.
 
Manufacturer Narrative
Product complaint # (b)(4). Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive. Further investigation of this individual incident will not be undertaken. 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.
 
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Brand NameUNKNOWN HIP FEMORAL AUGMENT
Type of DeviceHIP FEMORAL AUGMENT
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 Key8203058
MDR Text Key131619061
Report Number1818910-2018-79385
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
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 Received01/04/2019
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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