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

Catalog Number 5005-102L

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 11/04/2016

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

It was reported that the patient was complaining of pain and surgeon noticed a fracture of ulnar prosthesis on x-ray updated per rep 11/08/2016: the surgeon did say the prox portion loosened and caused a stress riser and that led to it breaking.It was in a few years.

• Brand Name: SM, 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6138708
• MDR Text Key: 61233223
• Report Number: 0002249697-2016-03802
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980502
• 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
• Report Date: 11/04/2016

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: 5005-102L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 12/01/2016
• 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): Other