MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ELEVATED RIM 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	643-00-36E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding damage involving a trident liner was reported.The event was confirmed via clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: confirmation: a revision surgery was performed.Metallosis, fracture of the femoral stem and extensive destruction of the polyethylene and locking mechanism were noted.Injuries and/or excessive levels of cobalt and chromium could not be confirmed.Root cause: the root cause of the revision was a ¿broken¿ femoral component.The root cause of the femoral failure and other findings cannot be determined without additional medical records.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's hip was revised due to excessive levels of chromium and cobalt in his blood, metallosis, fracture of the femoral stem and extensive destruction of the polyethylene and locking mechanism.Clinician review of provided medical records confirmed that a revision surgery was performed.Metallosis, fracture of the femoral stem and extensive destruction of the polyethylene and locking mechanism were noted.Injuries and/or excessive levels of cobalt and chromium could not be confirmed.The liner damage/ deformation is likely related to the fractured stem.However, the exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2008 and was revised on (b)(6) 2018.It is further alleged that he suffered injuries as a result of implantation and explantation of the devices at issue, device recall and excessive levels of cobalt and chromium in his blood.Update per clinician review: "a revision surgery was performed.Metallosis, fracture of the femoral stem and extensive destruction of the polyethylene and locking mechanism were noted.".

• Brand Name: TRIDENT X3 ELEVATED RIM 36MM ID
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13017971
• Report Number: 0002249697-2021-02051
• Device Sequence Number: 5188339
• Product Code: LPH
• UDI-Device Identifier: 07613327025064
• UDI-Public: 07613327025064
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 05/31/2013
• Device Model Number: 643-00-36E
• Device Catalogue Number: 643-00-36E
• Device Lot Number: 46TMJE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2008
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG