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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
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STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Catalog Number 0580-1-443
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Injury (2348); Reaction (2414)
Date of Event 08/13/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Notification of lfit hazard alert given to operating surgeon and he contacted patient to inform.Surgeon was advised that the patient required an early revision as had a tissue reaction.Surgeon reports that the patient has had subsequent problems.
 
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Brand Name
EXETER V40 STEM 44MM NO 3
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 Key7862251
Report Number0002249697-2018-02823
Device Sequence Number16635903
Product Code JDI
UDI-Device Identifier04546540153326
UDI-Public04546540153326
Combination Product (Y/N)N
Initial Reporter CountryNZ
PMA/510(K) Number
K173499
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/10/2018
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 Catalogue Number0580-1-443
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2018
Initial Report FDA Received Date09/10/2018
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;
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