MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIDENT CLUSTER CUP; UNKNOWN HIP DEVICE

Catalog Number UNK_REC

Device Problems Mechanical Problem (1384); Malposition of Device (2616); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

It was reported that the patient experienced recurrent dislocations and required revision surgery.

Manufacturer Narrative

An event regarding dislocation involving an trident shell was reported.A review by a clinical consultant confirmed trident shell malposition.Method and results: device evaluation and results: was not performed as the device was not returned medical records received and evaluation: a review of the provided medical records and or x-rays by a clinical consultant indicated: "discussion: at least third revision of trident shell with liner 1-year post previous revision due to recurrent dislocation in a female patient the principal problem is thus cup malposition in absent anteversion as evident by the straight line projection of the cup opening circle on the ap x-ray.Inclination of the cup is correct although no full pelvic x-rays is available that might allow still somewhat more accurate evaluation of cup inclination.Cup malposition is thus the underlying problem to contribute to impingement and dislocation problems.Principal root cause of failure thus was cup malposition leading to impingement and recurrent dislocation.Because cup position was the principal problem and the surgeon is responsible for optimal component placement, principal root cause of failure is procedure-related.This failure mode thus also applies to all previous revision surgeries.No evident patient-related factors are present, body weight was not really excessive.No indications for presence of device-related factors were seen.The problem of recurrent dislocation was already present early post primary arthroplasty and not completely solved by the previous two revision surgeries.As such is this pi case not device-related.Procedure-related factors: cup malposition in absent anteversion; previous revision surgeries with only insert and/or femoral head exchanges did not completely solve the underlying problem.Patient-related factors none evident.Device-related factors: none.Diagnosis: cup malposition in absent anteversion has contributed to impingement and stability problems in the arthroplasty causing recurrent dislocation.Previous revision surgeries in 2012 and 2015 with only insert and/or femoral head exchanges did not completely solve the underlying problem leading to another revision surgery in 2016 with full cup exchange which appears a more effective solution to the problem." conclusions: a review by a clinical consultant concluded: "cup malposition in absent anteversion has contributed to impingement and stability problems in the arthroplasty causing recurrent dislocation.Previous revision surgeries in 2012 and 2015 with only insert and/or femoral head exchanges did not completely solve the underlying problem leading to another revision surgery in 2016 with full cup exchange which appears a more effective solution to the problem." no further investigation for this event is possible at this time.Further information including operative reports, & follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be reopened.

Event Description

It was reported that the patient experienced recurrent dislocations and required revision surgery.

• Brand Name: UNKNOWN TRIDENT CLUSTER CUP
• Type of Device: UNKNOWN HIP DEVICE
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6118514
• MDR Text Key: 60574810
• Report Number: 0002249697-2016-03742
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 79