MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	723-00-36F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Joint Dislocation (2374); Ambulation or Postural Difficulties (2544)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding dislocation involving a trident liner was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: there was a revision surgery performed for acetabular loosening and bone loss with a pelvic discontinuity.The reconstruction was performed with a gap cup and the stem retained.There were subsequent dislocations and eventual failure of the reconstruction cage with dislocation and metallic implant fracture (by description).The hip was re-revised to a triflange construct and new modular stem.No radiographs were provided for review.Event confirmation: failure of a gap cup reconstruction can be confirmed.Root cause: the root cause was trauma combined instability and pelvic discontinuity." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient underwent closed reduction due to dislocation.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: there was a revision surgery performed for acetabular loosening and bone loss with a pelvic discontinuity.The reconstruction was performed with a gap cup and the stem retained.There were subsequent dislocations and eventual failure of the reconstruction cage with dislocation and metallic implant fracture (by description).The hip was re-revised to a triflange construct and new modular stem.No radiographs were provided for review.Event confirmation: failure of a gap cup reconstruction can be confirmed.Root cause: the root cause was trauma combined instability and pelvic discontinuity." 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.H3 other text : not returned to the manufacturer.
Event or Problem Description
This pi is for closed reduction performed on (b)(6) 2022.The patient had primary surgery (unknown if stryker components) in the right hip approximately the year 2011.A stryker construct was first recorded to be implanted in the patient's right hip on (b)(6) 2022.This revision procedure reportedly was intended to address the patient¿s chronic pain, a fall, dislocation, and polyethylene liner disassociation.A grossly loose acetabular component with proximal migration, transverse pelvic discontinuity, and massive acetabular bone loss were also reportedly observed at this time of primary stryker implantation.A bone graft was performed to address the acetabular fracture.Recurrent dislocations were then reported following this procedure and were first addressed on (b)(6) 2022 through closed reduction.Leading up to this august closed reduction, it was reported that "[the patient] participated in physical therapy last thursday and felt pain while walking with her walker back to her room in the rehab facility.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36F
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17394680
• Report Number: 0002249697-2023-00840
• Device Sequence Number: 5955715
• Product Code: LPH
• UDI-Device Identifier: 07613327342239
• UDI-Public: 07613327342239
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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 Catalogue Number: 723-00-36F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female
• Patient Weight: 61 KG
• Patient Race: White