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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

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DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS Back to Search Results
Catalog Number 121932450
Device Problem Device-Device Incompatibility (2919)
Patient Problem Not Applicable (3189)
Event Date 06/03/2019
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 50 +4 neutral marathon liner did not seat in a 50 sector porocoat cup (121722050 lot j3167y) correctly and was dreamed defective and was not implanted. Screw were used with the cup and was determined that each screw was seated in the cup correctly. The cup was determined to be defective and was not implanted. A new 50 +4 neutral marathon liner was implanted and seated correctly. The defective liner was thrown in the trash and will not be returning. Lot number has been referenced for the recorded. With 30 seconds surgical delay. Doe: (b)(6) 2019; unknown hip.

 
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Brand NamePINN MAR +4 NEUT 32IDX50OD
Type of DevicePINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
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, PA 19380-0988
6103142063
MDR Report Key8723592
MDR Text Key148956974
Report Number1818910-2019-96456
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK033273
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,Followup
Report Date 06/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121932450
Device LOT NumberJ0569D
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/08/2018
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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