MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	7115-0005
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding foreign matter involving a scorpio baseplate was reported.The event was not confirmed provided image.Method & results: product evaluation and results: the device was not returned but an image was attached to the complaint.The image shows the scorpio baseplate implanted in the patient and on the left side corner of the baseplate there is foreign matter that cannot be identified in the image.The event description states ¿a surgeon found a convexed metal (mis-processing) on the baseplate.¿ this cannot be verified with the image provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause determined because the device was not returned for evaluation.An image of the device was provided and shows the scorpio baseplate implanted in the patient and on the left side corner of the baseplate there is foreign matter that cannot be identified in the image.The event description states ¿a surgeon found a convexed metal (mis-processing) on the baseplate.¿ this cannot be verified with the image provided.No further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices becomes available to indicate further evaluation is warranted, this record will be reopened.Device remains implanted.
Event or Problem Description
It was reported that, during a tka (left side), a surgeon found a convexed metal (mis-processing) on the baseplate.The baseplate was already cemented so he forcibly inserted a pe insert on the baseplate.

• Brand Name: SERIES 7000 STANDARD TIBIA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7573393
• Report Number: 0002249697-2018-01717
• Device Sequence Number: 19403641
• Product Code: JWH
• UDI-Device Identifier: 07613327033342
• UDI-Public: 07613327033342
• Combination Product (Y/N): N
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 7115-0005
• Device Lot Number: 485W42
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR