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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPEDICS CORP. TRIDENT PSL HA CLUSTER ACETABULAR SHELL ; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL
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STRYKER ORTHOPEDICS CORP. TRIDENT PSL HA CLUSTER ACETABULAR SHELL ; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL Back to Search Results
Model Number 2023-02-11
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fall (1848); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Visual Impairment (2138); Anxiety (2328); Depression (2361); Numbness (2415); Palpitations (2467); Cognitive Changes (2551); Fluid Discharge (2686)
Event Date 12/21/2018
Event Type  Injury  
Event Description
After total hip replacement surgeries, swelling beyond normal, blistering, then open oozing for 4 months.Joint pains everywhere.Brain fog, blurred vision, fatigue, depression, accelerated heart rate, high blood pressure, anxiety, falling, skin hardening on feet and fingertip, numbness in fingertips and sinusitis.I ask for the components composition and in me is nickel 1.0 max.I've just completed my left revision surgery on (b)(6) 2019.I still have to have the right hip revised.I would like the fda to be there to take my implant and tissue for research.My surgeon is dr (b)(6).He was very skeptical about doing the revision because he didn't believe my symptoms were real.I was so upset.Do you have a picture of the product? yes.Fda safety report id# (b)(4).
 
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Brand Name
TRIDENT PSL HA CLUSTER ACETABULAR SHELL
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED METAL
Manufacturer (Section D)
STRYKER ORTHOPEDICS CORP.
MDR Report Key9362761
MDR Text Key167768215
Report NumberMW5091237
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model Number2023-02-11
Device Catalogue Number542-11-50E
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age49 YR
Patient Weight77
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