MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME PATELLA; IMPLANT

Catalog Number 73-3508

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/09/2015

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

This was a bilateral revision knee case that needed insert replacements.Patient was complaining of pain.No metal components were loose.Inserts were replaced on both sides and a patella was replaced on the left knee.This report is for the left knee.

Manufacturer Narrative

An event regarding the left scorpio insert replacement for an unknown reason involving a scorpio patella was reported.Conclusion: there were no allegations made against the reported scorpio patella and the device remains implanted.Based on the provided information, the product reported in this investigation did not contribute to the event.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

This was a bilateral revision knee case that needed insert replacements.Patient was complaining of pain.No metal components were loose.Inserts were replaced on both sides and a patella was replaced on the left knee.This report is for the left knee.

• Brand Name: SCORPIO U-DOME PATELLA
• Type of Device: IMPLANT
• 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: 5130078
• MDR Text Key: 27564444
• Report Number: 0002249697-2015-03262
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2006
• Device Catalogue Number: 73-3508
• Device Lot Number: H726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2001
• 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 Age: 84 YR
• Patient Weight: 61