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

Catalog Number 72-25-0918

Device Problems Break (1069); Material Discolored (1170); Fracture (1260); Scratched Material (3020)

Patient Problem Injury (2348)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicates the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that patient's knee (side not reported) was revised due to a broken post of the tibial insert.Surgeon elected to revise the patient to a larger insert (from 18 mm to 22 mm).

Manufacturer Narrative

An event regarding crack/fracture involving a scorpio insert was reported.The event was confirmed.A material analysis of the returned device conducted on (b)(6) 2017 concluded "post fracture abrasion obscured the fracture surface; no fracture surface analysis was possible.Abrasion damage was observed on the posterior portion of the post, consistent with cyclic contact with the femoral component.Burnishing, scratching, and third-body indentations were observed on the articulating surface, consistent with commonly-identified damage modes in uhmwpe inserts.No material or manufacturing defects were observed on the device features examined." no patient medical records were available for review.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.A material analysis of the returned device confirmed the event as abrasion damage consistent with cyclic contact with the femoral component was observed on the posterior portion of the post.However, post fracture abrasion obscured the fracture surface and hence no fracture surface analysis was possible.Burnishing, scratching, and third-body indentations consistent with commonly-identified damage modes in uhmwpe inserts were also observed on the articulating surface.No material or manufacturing defects were observed on the device features examined.

Event Description

It was reported that patient's knee (side not reported) was revised due to a broken post of the tibial insert.Surgeon elected to revise the patient to a larger insert (from 18mm to 22mm).

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7034465
• MDR Text Key: 92102522
• Report Number: 0002249697-2017-03364
• 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: 01/12/2018

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: 10/04/2011
• Device Catalogue Number: 72-25-0918
• Device Lot Number: 11NHX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 12/17/2017
• Supplement Dates FDA Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2006
• 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: 62 YR