MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME PATELLA; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	73-3508
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Additional 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 a 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 has been 1 other similar event for the lot referenced relating 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.A nc was raised to address this event.
Event or Problem Description
Implant reference number 73-3508 with lot numbers 53ti and y7x2 had a yellow ring around the diameter of the patella implant when opened.

• Brand Name: SCORPIO U-DOME PATELLA
• Common Device Name: 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18096795
• Report Number: 0002249697-2023-01364
• Device Sequence Number: 20488667
• Product Code: NPJ
• UDI-Device Identifier: 07613327033885
• UDI-Public: 07613327033885
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K052917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

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 Catalogue Number: 73-3508
• Device Lot Number: Y7X2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown