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

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).

• Brand Name: STRYKER REJUVENATE MODULAR HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 11337441
• MDR Text Key: 232357442
• Report Number: MW5099414
• Device Sequence Number: 1
• Product Code: MEH
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: REF NLS-420000B
• Device Lot Number: 32356801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 116