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

Catalog Number 502-11-54E

Device Problem Degraded (1153)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 10/21/2013

Event Type  Injury  

Event Description

The original information provided on 10/21/2013 indicated that the patient had an unknown rejuvenate/abg ii modular stem and neck implanted.At that time, the patient was asymptomatic and no adverse consequences or medical intervention were noted.Further information received on 03/18/2015 from the sales rep indicated: "the patient's right hip was being revised due to periprosthetic, greater troachcanter fracture.The doctor decided to also remove the shell to improve positioning.The liner was also explanted.".

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

Reported event: an event regarding femoral periprosthetic fracture involving an trident shell was reported.A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.Visual, dimensional and functional analysis could not be performed as the device was not returned.Conclusion: the shell does not contact the patient's femoral bone.There is no indication that the product reported in this investigation contributed to the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

The original information provided on (b)(6) 2013 indicated that the patient had an unknown rejuvenate/abg ii modular stem and neck implanted.At that time, the patient was asymptomatic and no adverse consequences or medical intervention were noted.Further information received on (b)(6) 2015 from the sales rep indicated: "the patient's right hip was being revised due to periprosthetic, greater trochanter fracture.The doctor decided to also remove the shell to improve positioning.The liner was also explanted.".

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430 NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4631982
• MDR Text Key: 5611093
• Report Number: 0002249697-2015-00895
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: 502-11-54E
• Device Lot Number: 32952001
• Other Device ID Number: STER. LOT 1003HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2010
• 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
• Patient Age: 67 YR