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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 G C.A.P. HUM HD TRIAL 52X18; SHOULDER INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 G C.A.P. HUM HD TRIAL 52X18; SHOULDER INSTRUMENT/TRIAL Back to Search Results
Catalog Number 223052010
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/19/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Event or Problem Description
It was reported that the global cap trial head broke into 3 pieces when impacting onto patient.
 
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
G C.A.P. HUM HD TRIAL 52X18
Common Device Name
SHOULDER INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6716798
Report Number1818910-2017-21208
Device Sequence Number16660609
Product Code LXH
UDI-Device Identifier10603295104902
UDI-Public10603295104902
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 06/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number223052010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/19/2017
Supplement Date Received by Manufacturer08/15/2017
Initial Report FDA Received Date07/17/2017
Supplement Report FDA Received Date08/15/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age56 YR
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