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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

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DEPUY ORTHOPAEDICS INC US APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT Back to Search Results
Model Number 1246-03-000
Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/21/2020
Event Type  Malfunction  
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

After the implantation of a pinnacle acetabular component and during the process of insertion, the apex hole eliminator protruded through the apex acetabular hole.

 
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Brand NameAPEX HOLE ELIM POSITIVE STOP
Type of DevicePINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no.299 changyang st
suzhou industrial park
suzhou jiangsu 21512 -6
CH 21512-6
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key9800324
MDR Text Key190810016
Report Number1818910-2020-07096
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
PMA/PMN NumberK963309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup,Followup
Report Date 02/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1246-03-000
Device Catalogue Number124603000
Device LOT NumberD19113602
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/04/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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