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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 60MM; HIP ACETABULAR CUP
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DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 60MM; HIP ACETABULAR CUP Back to Search Results
Catalog Number 121730060
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/05/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient was revised to address infection and cup loosening at the bone/implant interface.
 
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
PINN MULTIHOLE W/GRIPTION 60MM
Common Device Name
HIP ACETABULAR CUP
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key6916727
Report Number1818910-2017-25928
Device Sequence Number1408896
Product Code LPH
UDI-Device Identifier10603295010029
UDI-Public10603295010029
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K093646
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number121730060
Device Lot Number218526
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/05/2017
Supplement Date Received by Manufacturer05/24/2018
Initial Report FDA Received Date10/05/2017
Supplement Report FDA Received Date05/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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