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

Catalog Number 73-3110

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2015

Event Type  malfunction  

Manufacturer Narrative

The device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that an expired implant was used on a patient.

Manufacturer Narrative

An event regarding an alleged implantation of a scorpio patella that had passed its expiry date was reported.Conclusion: a review of the manufacturing records indicates a device manufacturing date of 08-may-2010 and an expiry date of 08-may-2015.The date for this event is indicated as (b)(6) 2015.Therefore the device was implanted passed its expiry date.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that an expired implant was used on a patient.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5368502
• MDR Text Key: 36049346
• Report Number: 0002249697-2016-00059
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 73-3110
• Device Lot Number: 0T84
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other