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

Catalog Number 72-25-1112

Device Problems Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales rep reported a knee revision surgery of which the scorpio insert broke.

Manufacturer Narrative

An event regarding a crack/fracture involving a scorpio insert was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis concluded: the post of the insert fractured in fatigue from the posterior to the anterior direction.Damage was observed on the posterior surface of the post consistent with contact against the femoral component.Post-fracture abrasion was also observed on the fracture surfaces examined.Burnishing, delamination, scratching and third-body indentations were observed on the condyles.These are common damage modes of uhmwpe.Yellow discoloration was also observed on the insert, consistent with absorption of synovial fluid.No material or manufacturing defects were observed on the surfaces examined.- medical records received and evaluation: no information was received for review with a clinical consultant.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the reported event could not be determined.A review of the material analysis indicated the post fractured in fatigue.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.No further investigation is required at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Sales rep reported a knee revision surgery of which the scorpio insert broke.

• Brand Name: SCORPIO-FLEX PS X3 TIB INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6443789
• MDR Text Key: 71180963
• Report Number: 0002249697-2017-01066
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051977
• 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: 06/01/2017

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: 03/31/2011
• Device Catalogue Number: 72-25-1112
• Device Lot Number: KMXMDA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2006
• 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: 75 YR