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 CROSSFIRE 10 DEG INSERT; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
  • 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 CROSSFIRE 10 DEG INSERT; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS. Back to Search Results
Model Number 2041C-2846
Medical Device Problem Code Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/12/2021
Type of Reportable Event Malfunction
Additional 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.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
 
Event or Problem Description
It was reported that during a revision tha, when a nurse opened the package, she noticed a disengaged locking wire.A spare insert was used instead.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CROSSFIRE 10 DEG INSERT
Common Device Name
HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key12745017
Report Number0002249697-2021-01824
Device Sequence Number4480123
Product Code JDI
UDI-Device Identifier04546540035714
UDI-Public04546540035714
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K974685
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/29/2025
Device Model Number2041C-2846
Device Catalogue Number2041C-2846
Device Lot Number77818001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/12/2021
Initial Report FDA Received Date11/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-