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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 RECLAIM DISTAL TAPERED 14X190 RECLAIM IMPLANT : HIP FEMORAL STEM

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DEPUY IRELAND 9616671 RECLAIM DISTAL TAPERED 14X190 RECLAIM IMPLANT : HIP FEMORAL STEM Back to Search Results
Catalog Number 197614190
Device Problems Fracture (1260); Off-Label Use (1494)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/29/2019
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 during proximal reaming with stem implant in place, the reamer plunged into the implant damaging the taper and surgeon had to upsize stem. Which also caused the proximal body to be wasted because next size implant sat up higher. Doe: (b)(6) 2019.

 
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Brand NameRECLAIM DISTAL TAPERED 14X190
Type of DeviceRECLAIM IMPLANT : HIP FEMORAL STEM
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9088025
MDR Text Key159322440
Report Number1818910-2019-105466
Device Sequence Number1
Product Code KWA
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 08/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number197614190
Device LOT NumberHF6934
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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