MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO NRG X3 PS TIBIAL INSERT #9 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	82-7-0908
Medical Device Problem Codes	Break (1069); Naturally Worn (2988)
Health Effect - Clinical Codes	Injury (2348); Joint Disorder (2373); Ambulation or Postural Difficulties (2544)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional 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 similar events for the lot referenced.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
Surgeon revised the knee as the patient was hyperextending.His plan was to increase poly thickness as patient has general ligament laxity.The surgeon has concerns that the post has broken and there is wear.Update 13/november/2019 wg: as reported in the communication log, originally reported by the rep: "the only product that was revised was the poly.The item revised today was 827-0908 scorpio tibial insert size 9, 8mm.The doctor reports that there is wear on the poly and it is broken.".
Event or Problem Description
Surgeon revised the knee as the patient was hyperextending.His plan was to increase poly thickness as patient has general ligament laxity.The surgeon has concerns that the post has broken and there is wear.Update 13/november/2019 wg: as reported in the communication log, originally reported by the rep: "the only product that was revised was the poly.The item revised today was 827-0908 scorpio tibial insert size 9, 8mm.The doctor reports that there is wear on the poly and it is broken.".
Additional Manufacturer Narrative
An event regarding crack/fracture, wear and instability involving a scorpio insert was reported.The event of crack/fracture and wear were confirmed via evaluation of the returned device; while the event of instability was not confirmed.Method & results -product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 20-jan-2020.The returned device was examined with the aid of a stereomicroscope at magnifications up to 50x.This inspection indicated that the post of the insert fractured in fatigue with final fracture occurring in overload, the fracture initiated on the anterior surface 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.The yellow discoloration of the insert was consistent with absorption of synovial fluid.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 was performed as part of the material analysis report (mar), dated 20-jan-2020.The returned device was examined with the aid of a stereomicroscope at magnifications up to 50x.This inspection indicated that the post of the insert fractured in fatigue with final fracture occurring in overload, the fracture initiated on the anterior surface 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.The yellow discoloration of the insert was consistent with absorption of synovial fluid.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 #9 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: 9444237
• Report Number: 0002249697-2019-03985
• Device Sequence Number: 16705031
• Product Code: JWH
• UDI-Device Identifier: 07613327031096
• UDI-Public: 07613327031096
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K071991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 06/30/2015
• Device Model Number: 82-7-0908
• Device Catalogue Number: 82-7-0908
• Device Lot Number: MJKD02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/13/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 82