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

Model Number 625-0T-32E

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device evaluated by manufacturer? not returned.

Event Description

Patient had dislocation of their left thr.

Event Description

Patient had dislocation of their left thr.

Manufacturer Narrative

Reported event:  an event regarding  dislocation involving trident liner was reported. the event was confirmed based on medical review.    method & results:  device evaluation and results: not performed as product was not returned.Clinician review:  a review of the provided medical records and/or x-rays by a clinical consultant indicated: the records were incomplete, and it was difficult to clearly determine a chronologic history.The patient was chronically unstable with multiple dislocations.Revision surgeries were required.The adm/mdm polyethylene disassociated from the head likely on attempted relocation.Obtaining the implants may help to determine if the locking mechanism was dysfunctional or if the disassociation was appropriate based on stresses applied.Device history review: indicate all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been 01 other similar events for the lot referenced.Conclusion:  an event regarding  dislocation involving trident liner was reported.The event was confirmed based on medical review.A review of the provided medical records and/or x-rays by a clinical consultant indicated: the records were incomplete, and it was difficult to clearly determine a chronologic history.The patient was chronically unstable with multiple dislocations.Revision surgeries were required.The adm/mdm polyethylene disassociated from the head likely on attempted relocation.Obtaining the implants may help to determine if the locking mechanism was dysfunctional or if the disassociation was appropriate based on stresses applied.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• 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
• MDR Report Key: 10438586
• MDR Text Key: 203901866
• Report Number: 0002249697-2020-01691
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2010
• Device Model Number: 625-0T-32E
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 12584102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR