MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER 50MM; IMPLANT

Catalog Number 502-01-50D

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 12/02/2014

Event Type  Injury  

Event Description

It was reported that loose acetabular shell was revised on left hip.

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, the evaluation summary will be submitted in a supplemental report.Device not returned to manufacturer.

Manufacturer Narrative

An event regarding loosening involving a trident shell was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a medical review was performed and concluded: "there is no evidence to suppose that device-related factors have played a role in the failure scenario.The rather significant cup malposition provides a very plausible explanation for an overload condition in the arthroplasty and as such should be considered more than adequate to cause the cup failure by loosening.Principal failure mode of this pi case is thus procedure-related with no information about potential secondary patient-related factors and no evidence for device-related factors.As such this pi case is not device-related." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: a medical review was performed and determined that there was no evidence of a device related issue.This device and event are determined to be within the scope of capa for trident loosening.

Event Description

It was reported that loose acetabular shell was revised on left hip.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER 50MM
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4354285
• MDR Text Key: 20782122
• Report Number: 0002249697-2014-04897
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Catalogue Number: 502-01-50D
• Device Lot Number: 23926001
• Other Device ID Number: STERILE LOT 0708XMI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2007
• 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
• Patient Age: 66 YR