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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
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STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Catalog Number 6570-0-232
Medical Device Problem Code Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/06/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received will be provided in a supplemental report.Not returned.
 
Event or Problem Description
A 36e liner was implanted with a 32+4 head.The patient was revised the same day.
 
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Brand Name
DELTA V-40 CERAMIC HEAD 32/+4
Common Device Name
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key7658955
Report Number0002249697-2018-02031
Device Sequence Number18862486
Product Code JDI
UDI-Device Identifier04546540608536
UDI-Public04546540608536
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K173499
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/03/2018
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 Expiration Date03/30/2023
Device Catalogue Number6570-0-232
Device Lot Number64277202
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2018
Initial Report FDA Received Date07/03/2018
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 Hospitalization; Required Intervention;
Patient Age43 YR
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