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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII NO8 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH ABGII NO8 CEMENTLESS LEFT V40; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 4845-0208
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
 
Event or Problem Description
Revision of abgii stem due to fracture of ceramic head and subsequent damage to trunnion.
 
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Brand Name
ABGII NO8 CEMENTLESS LEFT V40
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8812666
Report Number0002249697-2019-02621
Device Sequence Number19539032
Product Code LPH
UDI-Device Identifier07613327051070
UDI-Public07613327051070
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K121308
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/22/2019
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 Number4845-0208
Device Lot NumberGW29388291701
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/22/2019
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 Age63
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