MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-52E
Medical Device Problem Codes	Malposition of Device (2616); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: modular dual mobility insert; cat# 626-00-42e; lot# 76004202; restoration adm x3 ins 28/48; cat# 1236-2-848; lot# 76717901.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that following a primary total hip and a subsequent primary revision, the patient remained unsatisfied and a second revision was performed again (b)(6) 2021.The trident cup, mdm liner, and insert were removed with an explantation device.
Additional Manufacturer Narrative
An event regarding malposition involving a trident shell was reported.The event was confirmed following medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: this inquiry reports a case where a patient had total hip replacement and was ¿unsatisfied¿ and underwent revision surgery.Subsequently the patient was still ¿unsatisfied¿ and underwent another revision surgery.I can confirm that this event took place based on the information supplied by the stryker rep and photographs of xrays that seem to show excessive anteversion of the cup.Regarding the possible root cause of this event, i cannot determine it with certainty.Based upon the information supplied most likely the cause is malposition of the acetabular cup -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 has been 1 other similar event for the lot referenced.Conclusions: 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 primary 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.
Event or Problem Description
It was reported that following a primary total hip and a subsequent primary revision, the patient remained unsatisfied and a second revision was performed again (b)(6), 2021.The trident cup, mdm liner, and insert were removed with an explantation device.Update based on medical review: reason for revision was due to malposition of trident shell.

• Brand Name: TRIDENTII TRITANIUM CLUSTER52E
• Common Device Name: 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12298813
• Report Number: 0002249697-2021-01338
• Device Sequence Number: 3970414
• Product Code: LPH
• UDI-Device Identifier: 07613327343915
• UDI-Public: 07613327343915
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2024
• Device Model Number: 702-04-52E
• Device Catalogue Number: 702-04-52E
• Device Lot Number: 73672801A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown