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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MODULAR CATHCART BALL 46MM OD HIP ACETABULAR POLY/METAL HEMI

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DEPUY ORTHOPAEDICS, INC. 1818910 MODULAR CATHCART BALL 46MM OD HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number 136346000
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 11/13/2017
Event Type  Injury  
Manufacturer Narrative
This product was reported in error. No patient death, serious injury or evidence of reportable product malfunction occurred. Depuy considers the investigation closed at this time. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
 
Manufacturer Narrative
(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
The patient was revised to address pain. Doi: (b)(6) 2007. Dor: (b)(6) 2017. Right hip.
 
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Brand NameMODULAR CATHCART BALL 46MM OD
Type of DeviceHIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582
5743725905
MDR Report Key7104935
MDR Text Key109691399
Report Number1818910-2017-51239
Device Sequence Number1
Product Code LZY
UDI-Device Identifier10603295032786
UDI-Public10603295032786
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903084
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 11/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number136346000
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 Received12/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/06/2006
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: 12/11/2017 Patient Sequence Number: 1
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