MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-28D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is for the intervention for dislocation on (b)(6) 2021.No devices were revised.Total hip replacement left on (b)(6) 2012 in atx study.Luxation of the hip on (b)(6) 2017 and again on (b)(6) 2021.Repositioned and resolved.Update per sales rep: "these were no surgeries, the hip was repositioned twice.".
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device remains implanted.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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: "this patient underwent a primary total hip replacement in 2012 and then five years later sustained a dislocation.Approximately four years after that the patient sustained another dislocation.Both dislocations were reduced without consequence and the patient is now functioning well.I can confirm that the dislocations occurred since i was able to see office notes documenting the occurrences.The root cause of these events cannot be determined with certainty.Causes of dislocation five years and nine years after surgery are multifactorial.These include surgical technique factors such as proper soft tissue closure and restoration of soft tissue tension in the thigh.Patient had equal leg lengths.We do not have any information about the surgical approach to use but the fact that the dislocation occurred when the patient was in deep flexion it is possible that a posterior approach was used and the dislocation was posterior.It is possible that after several years the soft tissues can stretch allowing dislocation.It is also possible that polyethylene wear can contribute but there was no mention of any abnormality on the x-ray.Patient factors also come into play including activity level and bmi as well as movements which exceed the limits of reduction.Positional this location is not uncommon, especially with deep flexion and internal rotation.Implant factors would only come into play if there was significant polyethylene wear, or change in position of the implants.There is no evidence for these circumstances.I would not assign any causality to the implants 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 has been 1 other similar event for the lot referenced which relates to dislocation for the same device/patient; therefore, no further trending is required for this commonality.Conclusions: it was reported that the patient underwent a medical intervention to address dislocation of the head from the liner.It was not reported that any devices were explanted during this procedure.A review of the provided medical information by a clinical consultant indicated: "this patient underwent a primary total hip replacement in 2012 and then five years later sustained a dislocation.Approximately four years after that the patient sustained another dislocation.Both dislocations were reduced without consequence and the patient is now functioning well.I can confirm that the dislocations occurred since i was able to see office notes documenting the occurrences.The root cause of these events cannot be determined with certainty.Causes of dislocation five years and nine years after surgery are multifactorial.These include surgical technique factors such as proper soft tissue closure and restoration of soft tissue tension in the thigh.Patient had equal leg lengths.We do not have any information about the surgical approach to use but the fact that the dislocation occurred when the patient was in deep flexion it is possible that a posterior approach was used and the dislocation was posterior.It is possible that after several years the soft tissues can stretch allowing dislocation.It is also possible that polyethylene wear can contribute but there was no mention of any abnormality on the x-ray.Patient factors also come into play including activity level and bmi as well as movements which exceed the limits of reduction.Positional this location is not uncommon, especially with deep flexion and internal rotation.Implant factors would only come into play if there was significant polyethylene wear, or change in position of the implants.There is no evidence for these circumstances.I would not assign any causality to the implants itself." 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
This report is for the intervention for dislocation on (b)(6) 2021.No devices were revised.Total hip replacement left on (b)(6) 2012 in (b)(6) study.Luxation of the hip on (b)(6) 2017 and again on (b)(6) 2021.Repositioned and resolved.Update per sales rep: "these were no surgeries, the hip was repositioned twice.".

• Brand Name: TRIDENT 0° X3 INSERT 28MM 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17412980
• Report Number: 0002249697-2023-00848
• Device Sequence Number: 8741290
• Product Code: LPH
• UDI-Device Identifier: 07613327039382
• UDI-Public: 07613327039382
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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 Expiration Date: 04/30/2017
• Device Catalogue Number: 623-00-28D
• Device Lot Number: 39873401
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White