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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN REJUVENATE NECK; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number UNK_SHC
Device Problem Degraded (1153)
Patient Problem Metal Related Pathology (4530)
Event Date 06/22/2015
Event Type  Injury  
Event Description
It was reported that the patient is asymptomatic.Additional information received: plaintiff alleges the left rejuvenate hip implanted on (b)(6) 2010 failed causing pain and elevated metal ion levels.Plaintiff has not yet scheduled revision surgery.Additional information received from legal on 1/31/2024: it was reported through the filing of a lawsuit that allegedly the patient¿s rejuvenate modular left hip implanted on or about (b)(6), 2010 was revised on (b)(6) 2023.It is further alleged that the plaintiff suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.
 
Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.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 cocr is considered to be under the scope of this recall.No further investigation is required.
 
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Brand Name
UNKNOWN REJUVENATE NECK
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
EI   NA
Manufacturer Contact
joann ripoli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18775875
MDR Text Key336187065
Report Number0002249697-2024-00289
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,Consumer
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SHC
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/31/2024
Initial Date FDA Received02/26/2024
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexMale
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