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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, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_REJUVENATE STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problem Foreign Body Reaction (1868)
Event Date 09/16/2021
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. The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report. Voluntary recall ra 2012-067 was initiated for abgii and rejuvenate modular stems and necks due to the potential risks associated with these devices. The reported elevated levels of cobalt and chromium is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
Plaintiff was implanted with a left rejuvenate modular hip stem on (b)(6) 2011. Its further alleged that blood work revealed elevated levels of cobalt and chromium in bloodwork. The patients left hip was revised on (b)(6) 2021.
 
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Brand NameUNKNOWN_REJUVENATE STEM
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
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
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12606480
MDR Text Key276462461
Report Number0002249697-2021-01692
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
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: 10/11/2021 Patient Sequence Number: 1
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