MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #3 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	82-7-0308
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
On (b)(6) 2020, a female patient underwent tka procedure (right).On an unknown date, her knee was dislocated.On (b)(6) 2020, replaced the inserts.The reporter does not think it was due to a defect of the implant, but he would like to confirm the cause in the worn part.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation and wear involving a scorpio insert was reported.The event of dislocation was not confirmed but wear is confirmed via evaluation of the returned device.Method & results product evaluation and results: delamination, burnishing, scratching and third-body indentations were observed on the insert which are common damage modes on uhmwpe.Damage consistent with the explantation process was also observed on the insert.Impression markings consistent with contact against the baseplate were observed on the distal surface of the insert.Yellow discoloration consistent with absorption of synovial fluid was observed on the condyles of the insert.Based on the given information, no materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 06-feb-2013 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's knee was dislocated.The reporter does not think it was due to a defect of the implant, but he would like to confirm the cause in the worn part.Evaluation of the returned device indicated that delamination, burnishing, scratching and third-body indentations were observed on the insert which are common damage modes on uhmwpe.Damage consistent with the explantation process was also observed on the insert.Impression markings consistent with contact against the baseplate were observed on the distal surface of the insert.Yellow discoloration consistent with absorption of synovial fluid was observed on the condyles of the insert.Based on the given information, no 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.
Event or Problem Description
On (b)(6) 2020, a female patient underwent tka procedure (right).On an unknown date, her knee was dislocated.On (b)(6) 2020, replaced the inserts.The reporter does not think it was due to a defect of the implant, but he would like to confirm the cause in the worn part.

• Brand Name: SCORPIO NRG X3 PS TIBIAL INSERT #3 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10978539
• Report Number: 0002249697-2020-02619
• Device Sequence Number: 703140
• Product Code: JWH
• UDI-Device Identifier: 07613327030877
• UDI-Public: 07613327030877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 02/28/2018
• Device Model Number: 82-7-0308
• Device Catalogue Number: 82-7-0308
• Device Lot Number: MMAX6E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 03/12/2021
• 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