MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 56MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 502-01-56F

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 01/05/2017

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

Revision left total hip replacement for aseptic loosening.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 56MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6280518
• Report Number: 0002249697-2017-00345
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 502-01-56F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/05/2017
• 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 Age: 53 YR
• Patient Weight: 107
• Patient Outcome(s): Hospitalization; Required Intervention