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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE MODULAR 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); Injury (2348); Reaction (2414)
Event Date 05/04/2020
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 was implanted with a left rejuvenate modular hip stem on (b)(6) 2010. Its further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt and chromium in bloodwork.

 
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Brand NameUNKNOWN_REJUVENATE MODULAR 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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key10092691
MDR Text Key192207963
Report Number0002249697-2020-00981
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 07/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/2020
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 Received06/22/2020
Was Device Evaluated By Manufacturer? No
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: 05/27/2020 Patient Sequence Number: 1
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