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

Catalog Number 5005-002L

Device Problems Break (1069); Insufficient Information (3190)

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

Event Date 08/09/2013

Event Type  Injury  

Event Description

It was reported that the patient had ¿presented for follow-up and had a broken pin/axis of her total elbow arthroplasty.¿ surgery confirmed the broken pin and polyethylene bushing and replaced these items without complication.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding fracture involving a solar pin and bushing was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the devices were not returned for analysis.Medical records received and evaluation: insufficient records were provided for review.Device history review: all devices accepted into final stock met specification.Complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided for review.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported that the patient had "presented for follow-up and had a broken pin/axis of her total elbow arthroplasty." surgery confirmed the broken pin and polyethylene bushing and replaced these items without complication.

• Brand Name: STD, LT HUMERAL ASSEMBLY
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4453328
• MDR Text Key: 5422983
• Report Number: 0002249697-2015-00194
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,other,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

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 Expiration Date: 06/30/2013
• Device Catalogue Number: 5005-002L
• Device Lot Number: JJWMJE
• Other Device ID Number: STER. LOT MSLEKT0A2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2008
• 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; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 93