MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Complaint, Ill-Defined (2331)

Event Date 12/14/2014

Event Type  Injury  

Event Description

It was reported that patient bent over and fell then could not stand up.Patient went to hospital and was scheduled for surgery.Constrained was used and surgery was success.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Type of Device: IMPLANT
• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4445426
• MDR Text Key: 17266794
• Report Number: 0002249697-2015-00175
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 623-00-36E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/23/2015
• 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