MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-7-0708
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Our company representative reported that " knee surgery on (b)(6) 2015 came with the complaint of knee pain.During the revision surgery on (b)(6) 2019, doctor realized that the tibial ps insert rostrum was broken.".
Event or Problem Description
Our company representative reported that " knee surgery on (b)(6) 2015 came with the complaint of knee pain.During the revision surgery on (b)(6) 2019, doctor realized that the tibial ps insert rostrum was broken.".
Additional Manufacturer Narrative
Correction: update to lot code.An event regarding crack/fracture involving a scorpio insert was reported.The event was confirmed via evaluation of the returned device.Method & results.Product evaluation and results: visual inspection was performed as part of the material analysis report mar, dated 20-jan-2020.This inspection indicated that the returned tibial insert had fractured at the post.The fracture occurred in fatigue and propagated posteriorly.The damage on the articulating surface of the insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: visual inspection of the returned device indicated that the returned tibial insert had fractured at the post.The fracture occurred in fatigue and propagated posteriorly.The damage on the articulating surface of the insert was consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #7 8MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9340568
• Report Number: 0002249697-2019-03815
• Device Sequence Number: 11443571
• Product Code: JWH
• UDI-Device Identifier: 07613327031003
• UDI-Public: 07613327031003
• Combination Product (Y/N): N
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 82-7-0708
• Device Catalogue Number: 82-7-0708
• Device Lot Number: MMTMP1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention