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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP. STRYKER REJUVENATE MODULAR HIP IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER CORP. STRYKER REJUVENATE MODULAR HIP IMPLANT PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Model Number REF NLS-420000B
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2021
Event Type  Injury  
Event Description
A (b)(6) year old male underwent total right hip arthroplasty by dr. (b)(6) at (b)(6) hospital on (b)(6) 2021. Stryker rejuvenate modular stem and neck device implanted. On(b)(6) 2012 stryker issued a voluntary recall of the stryker rejuvenate modular stem and neck. All right total hip hardware explanted (b)(6) 2021 and revision total hip arthroplasty performed (b)(6) 2021. Fda safety report id # (b)(4).
 
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Brand NameSTRYKER REJUVENATE MODULAR HIP IMPLANT
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER CORP.
MDR Report Key11337441
MDR Text Key232357442
Report NumberMW5099414
Device Sequence Number1
Product Code MEH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2015
Device Model NumberREF NLS-420000B
Device Lot Number32356801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/16/2021 Patient Sequence Number: 1
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