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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME PATELLA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME PATELLA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM Back to Search Results
Catalog Number 73-3308
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646); Foreign Body In Patient (2687)
Event Date 01/16/2017
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.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 events for the lot referenced.
 
Event Description
Per sales rep revision of left primary knee.Patient brought to or due to suspected loosening, while surgeon was exposing left knee, it was noticed that a patella trial was left in soft tissue lateral to the joint.The patients patella implant was found to be loose.The surgeon did not think the patella trial that was left in the soft tissue had an impact on the patella implant loosening.There were no issues with the tibial insert.
 
Manufacturer Narrative
An event regarding loosening involving a scorpio patella was reported.The event was confirmed through the medical review.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: a medical review was performed and concluded: "compromise of vascular supply of the patella during knee arthroplasty with patellar resurfacing not rarely leads to avn of the patella with loss of bone support for the patellar device and consequent loosening requiring revision." -device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: a medical review was performed and concluded: "compromise of vascular supply of the patella during knee arthroplasty with patellar resurfacing not rarely leads to avn of the patella with loss of bone support for the patellar device and consequent loosening requiring revision." further to this the medical review did not indicate any evidence of a device related issue.No further investigation is required at this time.If further relevant information becomes available or the product is returned, this investigation will be re-opened.
 
Event Description
Per sales rep revision of left primary knee.Patient brought to or due to suspected loosening, while surgeon was exposing left knee, it was noticed that a patella trial was left in soft tissue lateral to the joint.The patients patella implant was found to be loose.The surgeon did not think the patella trial that was left in the soft tissue had an impact on the patella implant loosening.There were no issues with the tibial insert.
 
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Brand Name
SCORPIO U-DOME PATELLA
Type of Device
PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
suzanne neuschwanter
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6322535
MDR Text Key67136550
Report Number0002249697-2017-00533
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052917
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2011
Device Catalogue Number73-3308
Device Lot NumberY088
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age75 YR
Patient Weight59
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