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

Catalog Number 623-10-32F

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Mechanics Altered (2984); Positioning Problem (3009)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a primary left hip procedure.Surgeon attempted to seat and lock in liner but after three attempts was unsuccessful in getting the liner to seat and lock.Surgeon stated no soft tissue was in the way of the liner and sales rep retrieved another liner of same catalog number and size, provided to surgeon to complete the case.Surgical delay of ten minutes as a result of three tries to seat/lock the liner and to retrieve a new liner from stock by sales rep.

Manufacturer Narrative

An event regarding seating locking issue involving a trident 10° x3 insert was reported.The event was confirmed.Method & results: -device evaluation and results: the subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor indentation damage is noted around the back side of the device on both the hemispherical surface and the locking face.This damage appears consistent with debris trapped between the liner and shell.-medical records received and evaluation: medical records or x-rays were not provided for analysis.-device history review: review of the device history records indicate that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation determined the likely root cause of the event to be debris trapped between the mating faces of the liner and shell during insertion and attempted locking.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

During a primary left hip procedure.Surgeon attempted to seat and lock in liner but after three attempts was unsuccessful in getting the liner to seat and lock.Surgeon stated no soft tissue was in the way of the liner and sales rep retrieved another liner of same catalog number and size, provided to surgeon to complete the case.Surgical delay of ten minutes as a result of three tries to seat/lock the liner and to retrieve a new liner from stock by sales rep.

• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5042092
• MDR Text Key: 25249944
• Report Number: 0002249697-2015-02843
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 623-10-32F
• Device Lot Number: P08X7L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2014
• 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
• Patient Age: 78 YR