MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SCORPIO U-DOME X3 PATELLA; KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P

Catalog Number 73-20-3708

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); Injury (2348); No Code Available (3191)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Patient reported she had bilateral knee surgery in (b)(6) 2007.Patient had a broken patella component in the left knee in (b)(6) 2014 which was revised.

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.

Manufacturer Narrative

Corrected data: explant date was corrected per additional patient information received.An event regarding alleged a fracture involving a scorpio u-dome x3 patella was reported.The event was confirmed.Medical records received and evaluation: patient medical records were reviewed by a clinical consultant who noted the patient's surgeon removed fractured pieces from the patella by arthroscopy ((b)(6)-2014) and then by arthrotomy ((b)(6)-2014).Device history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: not performed as the lot # is unknown.Conclusions: the event was confirmed.Review of patient medical records indicated the patient underwent an arthroscopy to remove two loose parts of the patella implant on (b)(6)-2014.On (b)(6)-2014, the patient underwent an arthrotomy to replace the patella implant.During the arthrotomy, the surgeon noted that the pegs of the patella implant were still in the bone, indicating patella fracture occurred at the patella button/peg interface.Patient medical records were reviewed by a clinical consultant who noted the patient's surgeon removed fractured pieces from the patella by arthroscopy ((b)(6)-2014) and then by arthrotomy ((b)(6)-2014).No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.

Event Description

Patient reported she had bilateral knee surgery in (b)(6) 2007.Patient had a broken patella component in the left knee in (b)(6) 2014 which was revised.Update as per patient: on (b)(6) 2014 the patient underwent an arthroscopy to remove two pieces of the broken implant.She continued to experience pain so on (b)(6) 2014 she underwent an arthrotomy to replace the patella.

• Brand Name: SCORPIO U-DOME X3 PATELLA
• Type of Device: KNEE JOINT PATELLOFEMOROTIBIAL POLYMER/METAL/POLYMER SEMI-CONSTRAINED CEMENTED P
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4953819
• MDR Text Key: 6634523
• Report Number: 0002249697-2015-02515
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2014

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 Catalogue Number: 73-20-3708
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2014
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Weight: 70