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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

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STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number SPT-110000S
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 05/03/2013
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided 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 levels of cobalt and chromium revealed in bloodwork is considered to be under the scope of this recall. No further investigation is required. Device not returned.
 
Event Description
It was reported that the patient is asymptomatic. Additional information received from legal on 7/22/2020: plaintiff was implanted with a rejuvenate modular hip stem on his left hip on or about (b)(6) 2011. It is further alleged that the plaintiff had the left hip stem at issue explanted on (b)(6) 2019 due to elevated levels of cobalt an chromium revealed in bloodwork.
 
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Brand NameREJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11
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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key10401520
MDR Text Key202740007
Report Number0002249697-2020-01661
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2015
Device Catalogue NumberSPT-110000S
Device Lot NumberMHR791
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 Received08/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2010
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: 08/13/2020 Patient Sequence Number: 1
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