MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO-FLEX PS X3 TIB INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	72-25-0912
Medical Device Problem Codes	Break (1069); Unstable (1667)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.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 reported that no further information will be released by the hospital or surgeon.A supplemental report will be submitted upon completion of the investigation.".
Event or Problem Description
It was reported that the patient's left knee was revised after patient complaint of a feeling of looseness in the knee.Intra-operatively, the post of the ps insert was observed to be broken off.All pieces of the device were removed and a device of the same catalog number was implanted.Rep reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's left knee was revised after patient complaint of a feeling of looseness in the knee.Intra- operatively, the post of the ps insert was observed to be broken off.All pieces of the device were removed and a device of the same catalog number was implanted.Rep reported that no further information will be available.
Additional Manufacturer Narrative
Fda registration number corrected to 0002249697 - jr (howmedica) an event regarding crack/fracture involving scorpio insert was reported.The event was confirmed following the completion of a mar method & results: -device evaluation and results: visual inspection visual inspection was performed as part of the material analysis report (mar), dated 16 july 2019.This inspection indicated.[.] delamination, burnishing, scratching and third-body indentation were observed onthe insert dimensional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Functional inspection: not performed as the reported device was implanted and subsequently explanted.The device was returned damaged and in its current condition would not be an accurate reflection of its original manufactured condition.Material analysis material evaluation was completed and indicated the following comments: visual analysis yellow discoloration consistent with the absorption of synovial fluid was observed on the articulating surface of the insert.Delamination, burnishing, scratching and third-body indentation were observed on the insert.These are common damage modes of uhmwpe.Backside impression markings were observed on the distal surface of the insert, consistent with contact against the baseplate.Damages consistent with the explantation process was also observed on the insert.Beach markings were observed on the anterior portion fracture surface, indicating the device fractured in fatigue.The fatigue crack initiated on the posterior surface of the post and propagated toward the anterior surface.Wallner lines and hackles were also observed on the anterior surface of the post indicating that final fracture occurred in overload.The posterior surface of the post with damage being observed.This damage is likely due to contact with the femoral component.Conclusion the post of the insert fractured in fatigue with final fracture occurring in overload.Delamination, burnishing, scratching and third-body indentation were observed on the insert.These are common damage modes of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant -device history review: all devices 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.Conclusion: a material analysis concluded: the post of the insert fractured in fatigue with final fracture occurring in overload.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SCORPIO-FLEX PS X3 TIB INSERT
• 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: 8695347
• Report Number: 0009610726-2019-00001
• Device Sequence Number: 2275448
• Product Code: JWH
• UDI-Device Identifier: 07613327029710
• UDI-Public: 07613327029710
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/22/2019

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: 02/29/2016
• Device Catalogue Number: 72-25-0912
• Device Lot Number: MKDMRR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: 62 YR