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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT

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DEPUY ORTHOPAEDICS, INC. 1818910 APEX HOLE ELIM POSITIVE STOP PINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT Back to Search Results
Catalog Number 124603000
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 06/21/2019
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

It was reported that the surgeon could not insert the apex hole eliminator (p/n: 124603000) during the tha surgery on (b)(6) 2019. The surgeon had a difficulty to insert the apex hole eliminator because the groove of the apex hole eliminator did not fit with the cup. The apex hole eliminator was not inserted eventually to avoid prolonged surgical delay. The surgery was completed within a 30 minutes surgical delay. The apex hole eliminator was discarded due to infection.

 
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Brand NameAPEX HOLE ELIM POSITIVE STOP
Type of DevicePINNACLE HIP SYSTEM : HIP ACETABULAR AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 6
CH 215126
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8781951
MDR Text Key150751803
Report Number1818910-2019-98117
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 06/21/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number124603000
Device LOT NumberD19013909
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/21/2019
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: 07/11/2019 Patient Sequence Number: 1
Treatment
UNKNOWN HIP ACETABULAR CUP
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