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

Catalog Number 72-25-1110

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

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

It was reported that a patient had his legs crossed and felt a clunk when standing up.An scorpio post experienced a fracture.X3 superflex was the alleged part and was reported to be about 9 years old.Surgery was 7 days after the event to remove broken post and poly.

Manufacturer Narrative

An event regarding a fractured post involving a scorpio-flex ps x3 tib insert was reported.The event was confirmed.Method & results: -device evaluation and results: material analysis was performed and concluded that the "burnishing scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.The post of the insert fractured in fatigue, consistent with contact against the femoral component.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: 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 -complaint history review: there has been no other event for the lot referenced.Conclusions: the investigation concluded with the material analysis examination that "the post of the insert fractured in fatigue, consistent with contact against the femoral component.No material or manufacturing defects were observed on the surfaces examined." it was further noted that the device has been implanted for 9 years.

Event Description

It was reported that a patient had his legs crossed and felt a clunk when standing up.An scorpio post experienced a fracture.X3 superflex was the alleged part and was reported to be about 9 years old.Surgery was 7 days after the event to remove broken post and poly.

Manufacturer Narrative

Corrected data: brand name; catalog #; pma/510(k) #.Additional information: date of implant.

Event Description

It was reported that a patient had his legs crossed and felt a clunk when standing up.An scorpio post experienced a fracture.X3 superflex was the alleged part and was reported to be about 9 years old.Surgery was 7 days after the event to remove broken post and poly.

• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6039806
• MDR Text Key: 57855414
• Report Number: 0002249697-2016-03251
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 07/10/2017

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: 10/30/2011
• Device Catalogue Number: 72-25-1110
• Device Lot Number: 11MJA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; 06/12/2017
• Supplement Dates FDA Received: 01/05/2017; 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2006
• 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): Required Intervention