MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STD, LT ULNA COMPONENT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number 5005-202L

Device Problem Break (1069)

Patient Problems Fall (1848); Injury (2348)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

On 2011, solar elbow surgery was performed.The patient fell down on (b)(6) 2016.After a while, the breakage of the component was found and the revision surgery was performed on (b)(6) 2017.

Manufacturer Narrative

An event regarding crack/fracture involving a solar ulna was reported.The event was confirmed.Device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review but indicated that x-ray confirms event description.Further information such as patient demographics, op report, history are needed for completion of the assesment.Device history review: not performed as the device's lot id was not provided.Complaint history review: not performed as the device's lot id was not provided.Conclusions: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review but indicated that x-ray confirms event description.However the exact root cause of the event could not be determined as sufficient information was not provided.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

On 2011, solar elbow surgery was performed.The patient fell down on (b)(6) 2016.After a while, the breakage of the component was found and the revision surgery was performed on (b)(6) 2017.

• Brand Name: STD, LT ULNA COMPONENT
• Type of Device: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 6572676
• MDR Text Key: 75358244
• Report Number: 0002249697-2017-01570
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K980502
• 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: 10/24/2017

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 Catalogue Number: 5005-202L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/24/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR