MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII HEMI CLUSTER50D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-11-50D
Medical Device Problem Codes	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The site inquired if a patient can be a part of the trident ii revision study.However, in doing so, they mentioned that the patient already had a tha with trident ii tritanium acetabular shell, and the surgeon is planning to use multi hole instead of cluster hole this time.There is no other information available for the patient at this time.Proposed date of revision is (b)(6) 2022.
Event or Problem Description
The site inquired if a patient can be a part of the trident ii revision study.However, in doing so, they mentioned that the patient already had a tha with trident ii tritanium acetabular shell, and the surgeon is planning to use multihole instead of clusterhole this time.There is no other information available for the patient at this time.Proposed date of revision is (b)(6) 2022.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident ii shell was reported.The event was confirmed via clinician review.Method & results:  -device 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 medical records by a clinical consultant indicated: "this inquiry reports the early failure of a primary total hip acetabular prosthesis.No other implants contributed.The acetabular component should not be implicated as a cause of loosening unless implant analysis reveals some sort of defect in the fixation surface.The reported event is confirmed because i have read both the primary and revision operation reports.The root cause is not confirmed.Causes of early loosening of an acetabular component include inadequate acetabular preparation, inadequate sizing of the implant and inadequate final fixation.In my experience unless there was major physical trauma maneuvers of everyday living and physical therapy do not contribute.Infection can also cause loosening but no evidence of infection was found.Analysis of the fixation surface of the cup would be helpful to see if there was any issue but i would doubt this.There is no patient related factors that contributed nor any device-related factors." -device 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 reported lot.  conclusion: a review of medical records by a clinical consultant indicated: "this inquiry reports the early failure of a primary total hip acetabular prosthesis.No other implants contributed.The acetabular component should not be implicated as a cause of loosening unless implant analysis reveals some sort of defect in the fixation surface.The reported event is confirmed because i have read both the primary and revision operation reports.The root cause is not confirmed.Causes of early loosening of an acetabular component include inadequate acetabular preparation, inadequate sizing of the implant, and inadequate final fixation.In my experience unless there was major physical trauma maneuvers of everyday living and physical therapy do not contribute.Infection can also cause loosening but no evidence of infection was found.Analysis of the fixation surface of the cup would be helpful to see if there was any issue but i would doubt this.There is no patient related factors that contributed nor any device-related factors." further information such as pre and post operative xrays, return of device 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.

• Brand Name: TRIDENTII HEMI CLUSTER50D
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14468939
• Report Number: 0002249697-2022-00735
• Device Sequence Number: 17272123
• Product Code: LPH
• UDI-Device Identifier: 07613327381047
• UDI-Public: 07613327381047
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

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: 08/31/2026
• Device Model Number: 702-11-50D
• Device Catalogue Number: 702-11-50D
• Device Lot Number: 87413703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2021
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 50 KG