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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH UNITRAX MODULAR ENDO HEAD 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED Back to Search Results
Catalog Number 6942-5-048
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/11/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
 
Event or Problem Description
Hemi hip was originally revised (b)(6) 2019 due to dislocation.Surgeon removed the head and sleeve and converted to a total hip with mdm.Update 12/april/2019: rep provided implant sheets from the primary and revision surgeries, and reported that no further information will be available.
 
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Brand Name
UNITRAX MODULAR ENDO HEAD 48MM
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8592655
Report Number0002249697-2019-01888
Device Sequence Number11307664
Product Code JDI
UDI-Device Identifier07613327032413
UDI-Public07613327032413
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
PMA/510(K) Number
K173499
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/08/2019
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 Number6942-5-048
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2019
Initial Report FDA Received Date05/08/2019
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 Age79 YR
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