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

Catalog Number 73-3708

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 02/25/2014

Event Type  Injury  

Event Description

It was reported that the patients' right tibial baseplate was loose so the surgeon revised.

Manufacturer Narrative

An event regarding loosening involving a scorpio u-dome patella was reported.The event was confirmed.Device evaluation was not performed as no device was returned.A device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review confirmed no other similar events for the reported lot.A review of the provided medical records and x-rays by a clinical consultant indicated: ¿all components are evidently loose¿there are no reasons to assume that device-related factors were active in this case.Further clinical or laboratory info might provide more certainty regarding the conclusions in this case.¿ conclusions: the exact cause of the event could not be determined because of a lack of information.Further information such as clinical information, revision notes, pathology reports, and the reported device are needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and additional information become available, this investigation will be reopened.

Manufacturer Narrative

Event Description

It was reported that the patients' right tibial baseplate was loose so the surgeon revised.

• 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: 4086211
• MDR Text Key: 22266418
• Report Number: 0002249697-2014-03463
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 73-3708
• Device Lot Number: 12CFFB
• Other Device ID Number: STERILE LOT# MSL0707T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2007
• 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): Required Intervention
• Patient Age: 71 YR