MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #9 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/MET

Catalog Number 82-7-0910

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Fall (1848); Injury (2348)

Event Date 01/18/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient had a tka in 2014.She fell at home and "felt something".She went to surgery and the post had broken off the tibial insert.The surgeon replaced the damaged insert.

Manufacturer Narrative

An event regarding crack/fracture involving a scorpio insert was reported.The event was confirmed.Device evaluation and results: the visual inspection of the returned device was done and found that the post had broken off the tibial insert.Examination of the returned device with material analysis engineer indicated this is due to a traumatic event.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.On the basis of mar and visual inspection, the investigation concludes that the post had broken off the tibial insert and the device was fractured due to a traumatic event.Nothing more can be determined at this point of time.If additional information becomes available, this investigation will be reopened.

Event Description

Patient had a tka in 2014.She fell at home and "felt something".She went to surgery and the post had broken off the tibial insert.The surgeon replaced the damaged insert.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #9 10MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/MET
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6333278
• MDR Text Key: 67537608
• Report Number: 0002249697-2017-00578
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071991
• 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,Followup
• Report Date: 04/26/2017

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 Expiration Date: 10/31/2018
• Device Catalogue Number: 82-7-0910
• Device Lot Number: MMPRH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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: 66 YR