• 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 OMNIFIT DUAL GEOMETRY HA SHELL HIP IMPLANT

  • 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 OMNIFIT DUAL GEOMETRY HA SHELL HIP IMPLANT Back to Search Results
Catalog Number 2052-0050
Device Problem Loss of Osseointegration (2408)
Patient Problems Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Not returned.
 
Event Description
Patient presented with pain. Dr. (b)(6) removed a loose acetabular component and femoral head. He then replaced with a tritanium cup and mdm construct.
 
Manufacturer Narrative
An event regarding revision due to loosening involving an omnifit shell was reported. The event was not confirmed. Device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other similar events for the reported lot. The exact cause of the event could not be determined because insufficient information was provided. Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event. If further information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Patient presented with pain. Dr. Stewart removed a loose acetabular component and femoral head. He then replaced with a tritanium cup and mdm construct.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMNIFIT DUAL GEOMETRY HA SHELL
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-CORK
ida industrial estate
carrigtwohill NA
Manufacturer Contact
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7626747
MDR Text Key111975742
Report Number0002249697-2018-01920
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/1997
Device Catalogue Number2052-0050
Device Lot Number22877D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/1992
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/21/2018 Patient Sequence Number: 1
-
-