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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ARTICUL TR BALL GRVD 36 +1.5 HIP INSTRUMENTS : FEMORAL TRIALS

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DEPUY ORTHOPAEDICS, INC. 1818910 ARTICUL TR BALL GRVD 36 +1.5 HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Catalog Number 253151000
Device Problems Naturally Worn (2988); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  malfunction  
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
Instruments have become worn and gouged and require replacement. No patient consequence. No surgical delay.
 
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Brand NameARTICUL TR BALL GRVD 36 +1.5
Type of DeviceHIP INSTRUMENTS : FEMORAL TRIALS
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, IN 19380-0988
6103142063
MDR Report Key8600586
MDR Text Key144729102
Report Number1818910-2019-93175
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number253151000
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 Received07/17/2019
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 Unkown

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