• 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 GMRS PROXIMAL TIBIAL STANDARD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

  • 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 GMRS PROXIMAL TIBIAL STANDARD PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64953102
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2019
Event Type  malfunction  
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 reported lot. When completed, the evaluation summary will be submitted in a supplemental report.
 
Event Description
Standard proximal tibia (gmrs) 6495-3-102 was opened in the operating room. The non-sterile outer packaging was removed from the implant box. When peeling open the outer package to expose the inner sterile package, part of the outer plastic package was torn away with the peel away paper top. The inner sterile package appeared to be undamaged. Upon opening the inner sterile package, debris was found in around the proximal tibial implant. The debris appeared to be little white fibers or small particles of the paper seal from the inner sterile package. Questions arose regarding the integrity of the outer packaging and the subsequent sterility of the implant within the inner package. Surgeon decided not to implant the standard proximal tibia. The small proximal gmrs segment was substituted out of necessity. Tourniquet was inflated for 120 minutes, deflated for 20, then reinflated for 30 additional minutes, total tourniquet time 150 minutes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGMRS PROXIMAL TIBIAL STANDARD
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8367785
MDR Text Key137378563
Report Number0002249697-2019-01180
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023087
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 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number64953102
Device Lot Number068838R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2015
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: 02/25/2019 Patient Sequence Number: 1
-
-