MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO C-DOME PATELLA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number 73-2710

Device Problems Break (1069); Crack (1135); Fracture (1260); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient received an implant five years ago.It was reported that for the past year, the patient has been presenting with pain.It was reported that the patient underwent revision surgery.

Manufacturer Narrative

An event regarding a crack/fracture involving a scorpio patella was reported.The event was confirmed.Method & results: -device evaluation and results: a material analysis concluded burnishing and scratching were observed on the articulating surface of the returned patella insert.Fatigue was confirmed on the fractured patella peg.There is evidence of an elevated load in the region of the necked down fixation peg.There was no evidence of manufacturing or material defects on the returned ultra-high molecular weight polyethylene (uhmwpe) patella insert.-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 peg 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

It was reported that the patient received an implant five years ago.It was reported that for the past year, the patient has been presenting with pain.It was reported that the patient underwent revision surgery.

• Brand Name: SCORPIO C-DOME PATELLA
• 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: 6432140
• MDR Text Key: 70793523
• Report Number: 0002249697-2017-01000
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K962152
• 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: 05/31/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 73-2710
• Device Lot Number: LWXE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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