• 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 LRG TAP PRI MOD NCK 8DEG 30MM 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 LRG TAP PRI MOD NCK 8DEG 30MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC Back to Search Results
Catalog Number NLV-300800G
Device Problem Device-Device Incompatibility (2919)
Patient Problem Metal Related Pathology (4530)
Event Date 11/29/2021
Event Type  Injury  
Manufacturer Narrative
Reported event: an event regarding metallosis (wear) 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 were implanted. 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 metallosis (wear) is considered to be under the scope of this recall. No further investigation is required.
 
Event Description
It was reported that the patient's right hip was revised. Rep reported that metallosis was noted at both the neck-stem interface and on the trunnion. The rejuvenate modular stem construct, biolox head, and liner were revised to a competitor stem and head with another stryker liner. Rep confirmed that there are no allegations against the revised liner or head, and that no further information will be released by the hospital or surgeon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLRG TAP PRI MOD NCK 8DEG 30MM
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-CORK
ida industrial estate
carrigtwohill NA
EI NA
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13018548
MDR Text Key287901021
Report Number0002249697-2021-02058
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,Health Professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2015
Device Catalogue NumberNLV-300800G
Device Lot Number32516801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2010
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: 12/16/2021 Patient Sequence Number: 1
-
-