MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SCORPIO 7X10 INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number UNK_JR

Device Problem Degraded (1153)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

An event regarding alleged damage involving an unknown implant scorpio insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not received.Clinician review: no medical records were received for review with a clinical consultant.Product history review: not performed as device is not identified properly.Complaint history review: not performed as device is not identified properly.Conclusions: an event regarding alleged damage involving an unknown implant scorpio insert was reported.The event was not confirmed.The exact cause of the event could not be determined because product is not properly identified and no further investigation for this event is possible at this time as no devices was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

As reported: "right knee arthroplasty removal foreign body, revision polyethylene insert, possible patellar revision resurfacing.No further information available per hospital." per sales rep, the patellar component had become loose, and broken off cement (manufacturer unknown) had become ground into the poly insert.

• Brand Name: UNKNOWN SCORPIO 7X10 INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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 Key: 11810938
• MDR Text Key: 250193372
• Report Number: 0002249697-2021-00832
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 76