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

Model Number	723-00-36G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported a right hip dislocation and a revision due to an additional dislocation in (b)(6) 2023 where the head and liner were replaced.Update: patient had a revision due to dislocation on (b)(6) 2022 & on (b)(6) 2023.This pi is for revision on (b)(6) 2022.
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.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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Patient reported a right hip dislocation and a revision due to an additional dislocation in (b)(6) 2023 where the head and liner were replaced.Update: patient had a revision due to dislocation on (b)(6), 2022 & on (b)(6) 25, 2023.This pi is for revision on (b)(6), 2022.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed.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: "this patient underwent a primary right total hip arthroplasty through a posterior approach and four days after surgery required revision after a fall in which he sustained a posterior dislocation of the hip.A revision was carried out during which both components were changed.Following that revision the patient sustained for dislocations and approximately 1 year later he required another revision with insertion of a constrained liner.The root cause of this event cannot be determined with certainty.Causes of recurrent instability about the hip are multifactorial including surgical technique factors and patient factors including activity profile, and bmi.In this case trauma played a significant role.In this case the surgeon felt it was necessary to change both components in order to gain stability of the hip.Possibility of impingement as a contributing factor as well as the trauma can be considered.I would not assign any causality to the implant itself." -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.A review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary right total hip arthroplasty through a posterior approach and four days after surgery required revision after a fall in which he sustained a posterior dislocation of the hip.A revision was carried out during which both components were changed.Following that revision the patient sustained for dislocations and approximately 1 year later he required another revision with insertion of a constrained liner.The root cause of this event cannot be determined with certainty.Causes of recurrent instability about the hip are multifactorial including surgical technique factors and patient factors including activity profile, and bmi.In this case trauma played a significant role.In this case the surgeon felt it was necessary to change both components in order to gain stability of the hip.Possibility of impingement as a contributing factor as well as the trauma can be considered.I would not assign any causality to the implant itself." the exact cause of the event could not be determined because insufficient information was provided.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.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was confirmed.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: "this patient underwent a primary right total hip arthroplasty through a posterior approach and four days after surgery required revision after a fall in which he sustained a posterior dislocation of the hip.A revision was carried out during which both components were changed.Following that revision the patient sustained four dislocations and approximately 1 year later he required another revision with insertion of a constrained liner.Post revision xrays revealed satisfactory appearance of the constrained liner and total hip arthroplasty.The root cause of this event cannot be determined with certainty.Causes of recurrent instability about the hip are multifactorial including surgical technique factors and patient factors including activity profile, and bmi.In this case trauma played a significant role.In this case the surgeon felt it was necessary to change both components in order to gain stability of the hip.Possibility of impingement as a contributing factor as well as the trauma can be considered.I would not assign any causality to the implant itself." -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.A review of the provided medical records by a clinical consultant indicated: "this patient underwent a primary right total hip arthroplasty through a posterior approach and four days after surgery required revision after a fall in which he sustained a posterior dislocation of the hip.A revision was carried out during which both components were changed.Following that revision the patient sustained four dislocations and approximately 1 year later he required another revision with insertion of a constrained liner.Post revision xrays revealed satisfactory appearance of the constrained liner and total hip arthroplasty.The root cause of this event cannot be determined with certainty.Causes of recurrent instability about the hip are multifactorial including surgical technique factors and patient factors including activity profile, and bmi.In this case trauma played a significant role.In this case the surgeon felt it was necessary to change both components in order to gain stability of the hip.Possibility of impingement as a contributing factor as well as the trauma can be considered.I would not assign any causality to the implant itself." the exact cause of the event could not be determined because insufficient information was provided.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
Patient reported a right hip dislocation and a revision due to an additional dislocation in january 2023 where the head and liner were replaced.Update: patient had a revision due to dislocation on (b)(6) 2022 & on (b)(6) 2023.This pi is for revision on (b)(6) 2022.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36G
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17245217
• Report Number: 0002249697-2023-00740
• Device Sequence Number: 6707963
• Product Code: LPH
• UDI-Device Identifier: 07613327341706
• UDI-Public: 07613327341706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2023

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 Model Number: 723-00-36G
• Device Catalogue Number: 723-00-36G
• Device Lot Number: K7577N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 08/11/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/01/2023; 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG