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 UNKNOWN_JOINT REPLACEMENT_PRODUCT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
  • 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 UNKNOWN_JOINT REPLACEMENT_PRODUCT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number UNK_JR
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problems Injury (2348); Joint Dislocation (2374)
Event Date 02/14/2019
Event Type  Injury  
Manufacturer Narrative
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.Device not returned.
 
Event Description
Medical review for (revision due to dislocation and fracture of patella, right knee) provided the following additional information: "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation".Follow-up has already determined that no additional information will be available.
 
Event Description
Medical review for (revision due to dislocation and fracture of patella, right knee) provided the following additional information: "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation".Follow-up has already determined that no additional information will be available.
 
Manufacturer Narrative
An event regarding dislocation involving an unknown patella was reported.The event was confirmed by medical review.Method & results: -device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.-clinician review: the available medical records were provided to the consulting clinician for a review which was rejected stating - "x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components." -device history review: not performed as the device lot code was not available.-complaint history review: not performed as the device lot code was not available.Conclusions: it was reported that patient had a metal back patella which showed subluxation.The available medical records were provided to the consulting clinician for a review which was rejected stating that the x-ray confirms patella dislocation and post revision x-ray with new metal back patella shows subluxation, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components.The root cause could not be determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN_JOINT REPLACEMENT_PRODUCT
Type of Device
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8942356
MDR Text Key158870224
Report Number0002249697-2019-03016
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
Patient Weight73
-
-