MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; IMPLANT

Catalog Number 623-10-32G

Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/11/2015

Event Type  malfunction  

Event Description

It was reported, "that the insert (623-10-32g) did not locked the cup (542-11-58g) during medical procedure.So, another insert was implanted and it could be locked.".

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding seating/locking issues involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: the device was returned for analysis, scratching and damage was identified around the locking tab of the polyethylene insert consistent with attempts of implantation.Dimensional inspection: the device was within specification except feature 16 which is consistent with damage due attempted implantation.Functional inspection: not performed due to the damage identified in the visual inspection.-medical records received and evaluation: a medical review was not performed because insufficient information was provided.-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: the device was returned for analysis.Damage was identified around the locking tab of the polyethylene insert consistent with implantation attempts.There was no evidence of a dimensional issue on review of the device history record and no other events for the same lot have been reported.However, the exact cause of the event cannot be determined based on the information provided.Further information such as the operative report is needed to complete the investigation for determining root cause.No further investigation is possible at this time as insufficient information was received.If additional information becomes available the investigation will be reopened.

Event Description

It was reported, "that the insert (623-10-32g) did not locked the cup (542-11-58g) during medical procedure.So, another insert was implanted and it could be locked.".

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• 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 NJ NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4825285
• MDR Text Key: 5911569
• Report Number: 0002249697-2015-01821
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 623-10-32G
• Device Lot Number: 34692901
• Other Device ID Number: STERILE LOT# 1008V292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2010
• 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): Other