MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-10-32G

Device Problems Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); Insufficient Information (4580)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following device were also listed in this report: device name#32mm -4 v40 taper vit head ; cat#6260-5-032 ; lot#59154102 it cannot be determined which, if any of these device may have caused or contributed to the patient's experience.H3 other text : device not returned to the manufacturer.

Event Description

The patients liner and head was revised.

Manufacturer Narrative

Reported event; an event regarding dislocation involving a trident liner was reported.The event was confirmed through medical review.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: by report a patient underwent a revision hip surgery as well as an abductor transfer.The exact components were unclear but an mdm may have been implanted.It is unclear what transpired with this construct but the patient was implanted with a constrained liner.This constrained liner went on to fail with both a dislocation of the bipolar head from the constrained liner and dislodgement of the constrained liner from the trident shell.No preoperative or postoperative records were provided for review.Event confirmation: a dislocation of a constrained head and dislodgement of a constrained liner can be confirmed by x-ray.No other portions of the report can be confirmed.Root cause: the root cause of the failure of the constrained construct cannot be determined from the materials provided.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to dislocation of the head from the liner.A review of the provided medical records by a clinical consultant indicated: by report a patient underwent a revision hip surgery as well as an abductor transfer.The exact components were unclear but an mdm may have been implanted.It is unclear what transpired with this construct, but the patient was implanted with a constrained liner.This constrained liner went on to fail with both a dislocation of the bipolar head from the constrained liner and dislodgement of the constrained liner from the trident shell.No preoperative or postoperative records were provided for review.Event confirmation: a dislocation of a constrained head and dislodgement of a constrained liner can be confirmed by x-ray.No other portions of the report can be confirmed.Root cause: the root cause of the failure of the constrained construct cannot be determined from the materials provided.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Based on event update v40 head made as concomitant.

Event Description

The patients liner and head was revised.Additional information: it was reported that during first revision that the abductors were insufficient.Patient was leaning awkwardly out of his bed reaching for a light switch when the implant dislocated on this occasion.After the implantation of the mdm liner and new femoral head in this case, she completed a gluteus max transfer to replace abductors.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16945172
• MDR Text Key: 315366481
• Report Number: 0002249697-2023-00546
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039870
• UDI-Public: 07613327039870
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 623-10-32G
• Device Catalogue Number: 623-10-32G
• Device Lot Number: 58744101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• 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; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male