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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND¿ 9616671 CERAMAX CERAMIC INSERT 36 X 58; HIP ACETABULAR INSERT/LINER
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DEPUY IRELAND¿ 9616671 CERAMAX CERAMIC INSERT 36 X 58; HIP ACETABULAR INSERT/LINER Back to Search Results
Catalog Number 121887658
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Information (3190)
Date of Event 07/19/2017
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
It was reported that the hip was revised and found depuy ceramic liner had broken into pieces.
 
Additional Manufacturer Narrative
No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
CERAMAX CERAMIC INSERT 36 X 58
Common Device Name
HIP ACETABULAR INSERT/LINER
Manufacturer (Section D)
DEPUY IRELAND¿ 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key6804049
Report Number1818910-2017-23071
Device Sequence Number1541281
Product Code MRA
UDI-Device Identifier10603295012542
UDI-Public10603295012542
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 07/19/2017
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 Number121887658
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/19/2017
Supplement Date Received by Manufacturer12/08/2017
Initial Report FDA Received Date08/18/2017
Supplement Report FDA Received Date12/08/2017
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 Age42 YR
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