MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-36G

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348); Joint Dislocation (2374); No Code Available (3191)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Right hip revision.Patient had three hip dislocations.

Manufacturer Narrative

An event regarding dislocation involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a review of the provided medical records by a clinical consultant indicated: "no evidence is present to suggest that device-related factors did play a role, this is never the case with instability failure scenario¿s.Instability is a "soft tissue¿ problem that can be solved with metallic devices but their size, position and other geometry aspects all play a decisive role in this aspect and not the specific device properties as related to manufacturing or materials composition." "a traumatic fall a few months before revision in 2016, caused the soft tissue envelope around the arthroplasty to become incompetent to retain the femoral head in the liner which together with a prior muscle incompetency due to polio muscle disease triggered a new episode of recurrent dislocations requiring revision surgery." 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: a review of the provided medical records concluded: "a traumatic fall a few months before revision in 2016, caused the soft tissue envelope around the arthroplasty to become incompetent to retain the femoral head in the liner which together with a prior muscle incompetency due to polio muscle disease triggered a new episode of recurrent dislocations requiring revision surgery." no further investigation for this event is possible at this time.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Right hip revision.Patient had three hip dislocations.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6199101
• MDR Text Key: 63125003
• Report Number: 0002249697-2016-03997
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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: 02/26/2017

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 Expiration Date: 04/30/2009
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 9022803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2004
• 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: 107