MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME X3 PATELLA; IMPLANT

Catalog Number 73-20-3708

Device Problem Fracture (1260)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device and medical records were not made available to the manufacturer due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Patient presented with pain and lack of motion 7 years post left tka surgery.X-rays showed that the patella component was no longer attached.Revision surgery was performed today.Upon exposing the joint the patella component was identified as having sheared off and the pegs remained in the bone.There was some lateral wear noticed on the patella.Dr.(b)(6) replaced the patella and decided to replace the tibial insert as well because it was seven years old.Neither component had identifiable lot codes.

• Brand Name: SCORPIO U-DOME X3 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5110456
• MDR Text Key: 26983261
• Report Number: 0002249697-2015-03175
• 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
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 73-20-3708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 88