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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 73-3708
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2023
Event Type  malfunction  
Manufacturer Narrative
An event regarding appearance involving a scorpio patella was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection on the returned device indicated yellow discoloration of the patella.Material analysis: material analysis was performed on ultra-high molecular weight polyethylene (uhmwpe) barstock as part of an nc.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 2 other similar events for the lot referenced which relate to appearance.Conclusions: it was reported that a scorpio universal patella was observed to be discolored upon opening the sterile packaging.The event was confirmed via evaluation of the returned device.An nc was raised to address this event.
 
Event Description
73-3708 lot jr5n came out of the box yellow.
 
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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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key18097331
MDR Text Key327707837
Report Number0002249697-2023-01370
Device Sequence Number1
Product Code NPJ
UDI-Device Identifier07613327033892
UDI-Public07613327033892
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 Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number73-3708
Device Lot NumberJR5N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2023
Date Manufacturer Received11/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2022
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) Other;
Patient SexMale
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