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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL MULTI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL MULTI; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number 508-11-54E
Medical Device Problem Code Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/05/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An event regarding foreign matter (hair on the packaging) with a trident shell was reported.The event was confirmed through visual inspection.
 
Event or Problem Description
It was reported that there was a hair between a label and a bag, and it was discarded.The procedure was successful using other one.
 
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Brand Name
TRIDENT HEMISPHERICAL MULTI
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 Key8390142
Report Number0002249697-2019-01251
Device Sequence Number13941860
Product Code LPH
UDI-Device Identifier04546540432216
UDI-Public04546540432216
Combination Product (Y/N)N
PMA/510(K) Number
K143085
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2023
Device Catalogue Number508-11-54E
Device Lot Number66417401
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2019
Initial Report FDA Received Date03/05/2019
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 Other;
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