Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 10; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
  • 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 10; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number SPT-100000S
Device Problems Device-Device Incompatibility (2919); Insufficient Information (3190)
Patient Problems Inflammation (1932); Pain (1994); Reaction (2414)
Event Date 05/12/2020
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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
It was reported that; patient is experiencing some pain in right hip.Patient also states that he has to lean sideways when driving.Patient has a pending appointment to have blood work and x-rays done on (b)(6) 2012 at the hospital where he had the surgery.Patient has also had a left hip implanted at the same time as the right hip, but left hip is currently asymptomatic.Information received from legal on 5/12/2020: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2011 failed due to elevated levels of cobalt and chromium revealed in bloodwork.Revision not yet scheduled.
 
Manufacturer Narrative
Reported event: an event regarding elevated metal ions involving a rejuvenate modular device was reported.The event was confirmed.Method & results: device evaluation and results: device evaluation was not performed as no devices were received.Device history review: review of device history records found the devices in the reported lot were accepted into final stock with no reported discrepancies.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.Conclusions: 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 metal ions is considered to be under the scope of this recall.No further investigation is required.
 
Event Description
It was reported that; patient is experiencing some pain in right hip.Patient also states that he has to lean sideways when driving.Patient has a pending appointment to have blood work and x-rays done on (b)(6) 2012 at the hospital where he had the surgery.Patient has also had a left hip implanted at the same time as the right hip, but left hip is currently asymptomatic.Information received from legal on 5/12/2020: the plaintiff alleges that the right rejuvenate modular hip stem implanted on (b)(6) 2011 failed due to elevated levels of cobalt and chromium revealed in bloodwork.Revision not yet scheduled.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 10
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key10124658
MDR Text Key194317605
Report Number0002249697-2020-01036
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K092561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/23/2016
Device Catalogue NumberSPT-100000S
Device Lot NumberMKEW18
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2090-2012
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-