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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER ORTHOPAEDICS-CORK TRIDENT 10 X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Model Number 623-10-32E
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured, and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
 
Event or Problem Description
The insert did not fit the acetabular shell.Significant medical history of the patient: obesity.
 
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Brand Name
TRIDENT 10 X3 INSERT 32MM ID
Common Device Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI  NA
MDR Report Key10605792
Report Number0002249697-2020-02020
Device Sequence Number11433689
Product Code LPH
UDI-Device Identifier07613327039856
UDI-Public07613327039856
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K033716
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/30/2020
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 Date06/01/2023
Device Model Number623-10-32E
Device Catalogue Number623-10-32E
Device Lot Number65843801
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/04/2020
Initial Report FDA Received Date09/30/2020
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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