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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED Back to Search Results
Catalog Number UNK_JR
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Event Date 04/02/2020
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Information received from legal : plaintiff alleges right rejuvenate hip implanted on or about (b)(6) 2010 that failed causing pain and elevated metal ion levels. Plaintiff has not yet undergone revision surgery.

 
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Brand NameUNKNOWN REJUVENATE STEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
diana rogers
210 centennial avenue
centennial park, elstree
borehamwood, NJ WD6 3-SJ
GB   WD6 3SJ
2018315000
MDR Report Key10013101
MDR Text Key189500025
Report Number0002249697-2020-00837
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 Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2090-2012

Patient TREATMENT DATA
Date Received: 04/30/2020 Patient Sequence Number: 1
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