MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO SUPERFLEX CR TIBIAL; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 72-6-0708

Device Problems Degraded (1153); Material Integrity Problem (2978); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 03/31/2016

Event Type  Injury  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

Poly liner exchange scheduled.Replaced with x3 poly.

Manufacturer Narrative

An event regarding wear were reported.The events was confirmed.Method and results: -device evaluation and results: visual inspection was performed as part of the material analysis report , it noted "the damage observed is consistent with in vivo service related damages from 13 years of use"."burnishing, scratching, third-body indentations, and delamination were observed on the articulating surface, which are consistent with commonly-identified damage modes in uhmwpe inserts.No material or manufacturing defects were observed on the device features examined".A review by a clinical consultant noted: "as such it appears very unlikely that device-related matters have contributed to the problem, as also supported by the mar findings but that bearing exchange was more dictated by procedure-related factors of access to the knee and not related to the actual failure mode of the knee.Details remain however obscure due to limited clinical information and absence of x-rays".Conclusions: "no material or manufacturing defects were observed on the device features examined" the exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, operative reports, x-rays, patient history and follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be reopened.

Event Description

Poly liner exchange scheduled.Replaced with x3 poly.

• Brand Name: SCORPIO SUPERFLEX CR TIBIAL
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5611767
• MDR Text Key: 43781851
• Report Number: 0002249697-2016-01368
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K033971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 72-6-0708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 79 YR