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

Catalog Number 502-11-52E

Device Problems Component Missing (2306); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2015

Event Type  malfunction  

Event Description

The surgeon requested a 52mm trident cup for his implant.Upon opening the box, the rep noticed it appeared to be missing it's ha coating.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding missing ha coating involving a trident shell was reported.This event was not confirmed.Method & results: -device evaluation and results: visual inspection confirmed that the ha coating was present on all parts of the returned devices.There was however evidence of discolouration noted on the returned devices which is consistent with exposure to gamma radiation -medical records received and evaluation: not performed as the device was not implanted and there was no patient details reported.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies -complaint history review: a review of the complaint history database shows that there has been one similar reported events for the subject lot code.Pr was opened to investigate appearance for the same issue at the same hospital conclusions: an event regarding missing ha coating was reported.Visual inspection confirmed that the ha coating was present on all parts of the returned devices.Discolouration of the coating was observed.Discoloration may occur during exposure to gamma radiation and can exhibit a light tan or brownish colouration on some ha coatings.The type and level of discoloration on the returned devices is consistent with that covered under the scope of technical assessment.This report assessed ha coated product and determined that discoloured ha products meet the in-house specifications for organic residuals and metal trace elements and do not have an adverse impact.

Event Description

The surgeon requested a 52mm trident cup for his implant.Upon opening the box, the rep noticed it appeared to be missing it's ha coating.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4621060
• MDR Text Key: 17934640
• Report Number: 0002249697-2015-00795
• 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: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 502-11-52E
• Device Lot Number: 50105101
• Other Device ID Number: STER. LOT 1501DCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2015
• 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): Other