• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU Back to Search Results
Catalog Number SPT-080000S
Device Problem Device-Device Incompatibility (2919)
Patient Problems Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Event Date 04/01/2015
Event Type  Injury  
Manufacturer Narrative
Complaint history review: the complaint databases show there have been other events for the reported lot. Similar events have occurred for the catalog number and product family. These events were determined to be associated with ra 2012-067. 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 pain and elevated levels is considered to be under the scope of this recall. No further investigation is required. Not returned to the manufacturer.
 
Event Description
Information received from broadspire: it was reported that the patient has pain, metallosis - elevated levels of chromium & cobalt, clicking noise. Additional information received from legal: plaintiff alleges the left rejuvenate hip implanted on or about (b)(6) 2010 failed causing pain and elevated metal ion levels. Plaintiff has not yet scheduled revision surgery. As reported by rep: "revision of left total hip. Patient had rejuvenate stem removed. Patient cobalt level was 18. " spoke to rep. A rejuvenate modular stem and neck, and cocr head were revised. Rep confirmed that no further information will be released by the hospital or surgeon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
Type of DevicePROSTHESIS, 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-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13308180
MDR Text Key288700457
Report Number0002249697-2022-00110
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 Other,Consumer
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2015
Device Catalogue NumberSPT-080000S
Device Lot NumberMHTMHP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/28/2010
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: 01/20/2022 Patient Sequence Number: 1
-
-