MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG CONSTRAINED INSERT 22E; IMPLANT

Catalog Number 690-00-22E

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/09/2015

Event Type  Injury  

Event Description

The patient's right hip was revised due to the constrained liner disassociating from itself.The surgeon believes there was impingement and wear as if it was rubbing against the neck.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Hospital retained.

Manufacturer Narrative

An event regarding disassociation involving a trident 0 degree liner was reported.The event was confirmed.Method and results: device evaluation and results: visual, dimensional & functional inspection was not performed as no items were returned.Medical records received and evaluation: clinical consultant concluded that there is no examination of the explanted constrained liner, no revision operative report, and no x-rays of a disassociated constrained liner available.Device history review: review of the device history records indicates all devices accepted into final stock met specifications.Complaint history review: there have been no other events for this lot.Conclusions: the exact cause of the event could not be determined because there is no examination of the explanted constrained liner, no revision operative report, and no x-rays of a disassociated constrained liner available as mention by the consulting clinician.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

Event Description

The patien'ts right hip was revised due to the constrained liner disassociating from itself.The surgeon believes there was impingement and wear as if it was rubbing against the neck.

• Brand Name: TRIDENT 0 DEG CONSTRAINED INSERT 22E
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4745731
• MDR Text Key: 15901282
• Report Number: 0002249697-2015-01444
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061654
• 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
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 690-00-22E
• Device Lot Number: MMP8LM
• Other Device ID Number: STERILE LOT# MSLMR18A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2013
• 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: 74 YR
• Patient Weight: 77