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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 32 +0 FEMORAL HEAD TRIALS, REP HIP INSTRUMENTS : FEMORAL TRIALS

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DEPUY ORTHOPAEDICS INC US 32 +0 FEMORAL HEAD TRIALS, REP HIP INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 87-5928
Device Problems Scratched Material; Illegible Information
Event Date 03/24/2020
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

It was reported that the instruments are scratched up or damaged and sizes can¿t be read or identified easily. No surgical delay.

 
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Brand Name32 +0 FEMORAL HEAD TRIALS, REP
Type of DeviceHIP INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9919390
Report Number1818910-2020-10107
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number87-5928
Device Catalogue Number875928
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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