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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5 HIP CERAMIC FEMORAL HEADS

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DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5 HIP CERAMIC FEMORAL HEADS Back to Search Results
Catalog Number 136532320
Device Problems Corroded (1131); Naturally Worn (2988); Noise, Audible (3273)
Patient Problems Pain (1994); Scarring (2061); Tissue Damage (2104); Injury (2348)
Event Date 07/28/2017
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.
 
Event Description
Alleges that the patient sustained injuries related to the pinnacle hip replacement. Doe: (b)(6) 2017 (unknown hip).
 
Manufacturer Narrative
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, will be filed as appropriate.
 
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Brand NameDELTA CER HEAD 12/14 32MM +5
Type of DeviceHIP CERAMIC FEMORAL HEADS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 19380-0988
6103142063
MDR Report Key7348244
MDR Text Key102719881
Report Number1818910-2018-55392
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2018
Device Catalogue Number136532320
Device Lot Number6975715
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 Received11/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/25/2013
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: 03/19/2018 Patient Sequence Number: 1
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