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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP STRYKER TRITANIUM HEMISPHERICAL CLUSTER ACETABULAR COMPONENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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STRYKER CORP STRYKER TRITANIUM HEMISPHERICAL CLUSTER ACETABULAR COMPONENT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Failure of Implant (1924)
Event Date 11/16/2018
Event Type  Injury  
Event Description
Experienced continual pain in right hip, originating roughly 2.5 years after tha, done in (b)(6) 2016.Diagnosed on x-ray and with follow up lab testing with aseptic loosening of stryker tritanium hip implant placed in (b)(6) 2016.Xrays done in (b)(6) 2018, showing failure of acetabular part of implant to bond with bone.Confirmed on x-ray (b)(6) 2019, with second opinion indicating the revision surgery will be required.All laboratory testing was negative and other causes loosening were ruled out by second surgeon.Tritanium composition material used in stryker implant has been associated with elevated rates of these implants in hip replacement surgery.Scheduling of revision surgery will be dependent on progression of clinical symptoms.Aseptic loosening of hip imp.Fda safety report id # (b)(4).
 
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Brand Name
STRYKER TRITANIUM HEMISPHERICAL CLUSTER ACETABULAR COMPONENT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER CORP
MDR Report Key8658669
MDR Text Key146901515
Report NumberMW5087049
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 05/27/2019
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/30/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age74 YR
Patient Weight56
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