MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO CR TIB INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 72-2-0910

Device Problem Material Deformation (2976)

Patient Problems Pain (1994); Injury (2348); Osteolysis (2377)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: scorpio rt cr cemented femur, scorpio right cr femur ; cat# unk ; lot# unk.Series 7000 standard tibia; 7115-0009 ; t04k423.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient had a scorpio right total knee done 12-15 years ago by another surgeon.No records or additional information is available about the primary surgery.Patient did well until recently.He began to have pain on ambulation.He went for an evaluations.On xray he showed modest signs of osteolysis.He was scheduled for revision surgery.Components we were removed.There was modest poly wear noted by the surgeon.The knee was prepped for a triathlon ts.The operation was completed successfully.

• Brand Name: SCORPIO CR TIB INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: bradley curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7586530
• MDR Text Key: 110605066
• Report Number: 0002249697-2018-01752
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033971
• 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: 06/11/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2008
• Device Catalogue Number: 72-2-0910
• Device Lot Number: 97049601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2003
• 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: 86 YR
• Patient Weight: 86