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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 No Apparent Adverse Event (3189)
Patient Problems Cardiac Arrest (1762); Infarction, Cerebral (1771)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Ppf alleges stroke and heart attack after first revision. Head and liner were non-depuy.

 
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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)
JJM (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-XXXX
6107428552
MDR Report Key8519884
MDR Text Key142116935
Report Number1818910-2019-90829
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK963309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number124603000
Device LOT NumberD10020037
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 Received05/06/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/24/2010
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: 04/16/2019 Patient Sequence Number: 1
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