MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; IMPLANT

Catalog Number 502-11-52E

Device Problems Device Slipped (1584); Device Inoperable (1663)

Patient Problem Fall (1848)

Event Date 01/16/2014

Event Type  Injury  

Event Description

(b)(6) 2014: the tha was done for oa.(b)(6) 2014: the loosening of the trident cup was occured because the patient fell.It was noted by the doctor that the cup was not completely covered acetabular because the cover of the back wall of the acetabular is slight.It might have needed a screw fixed.

Event Description

(b)(6) 2014: the tha was done for oa.(b)(6) 2014: the loosening of the trident cup was occured because the patient fell.It was noted by the doctor that the cup was not completely covered acetabular because the cover of the back wall of the acetabular is slight.It might have needed a screw fixed.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding loosening involving a trident shell was reported.The event was not confirmed.The shell was returned assembled with the mdm liner.The shell has sparse areas of fibrous on-growth in the coated surface.Review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Review indicated there have been no other events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes, and x-rays are needed to fully investigate the event.If further information becomes available , this investigation will be re-opened.Product surveillance will continue to monitor for trends.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Type of Device: IMPLANT
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3608823
• MDR Text Key: 4090392
• Report Number: 0002249697-2014-00324
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013676
• 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,Followup
• Report Date: 01/20/2014

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 45318501
• Other Device ID Number: STER. LOT 1309PCM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 02/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/23/2013
• 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