MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 DEG X3 INSERT 32F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	723-10-32F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Joint Dislocation (2374)
Date of Event	03/13/2024
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
It was reported by sales representative that patient did rthr revision on (b)(6) 2024.Had his right hip dislocated and proximal femur fracture in early february when patient crossed his legs.Been on traction treatment, and did his second rthr revision.Dr.Changed from normal trident 2 liner to constrained liner.Also, dall miles beaded wire was sued to fix the proximal femur fracture.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving a trident liner was reported.The event was not 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: "confirmation of event: i can confirm that the patient had a right total hip arthroplasty at some point in the past with a cementless cup and a long stem cementless femoral component.I can also confirm that the patient developed a fracture of the greater trochanter.I was able to see x-rays with the implant and the fracture in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of late fracture of the greater trochanter following total hip arthroplasty are multifactorial including surgical technique and patient factors including lifestyle, activity level and bmi.The cause of the initial fracture cannot be determined with certainty but trauma may have played a role.After revision the patient apparently crossed his legs and this apparently contributed to a re-fracture after the first revision.If fixation was not adequate than crossing one's leg in the initial postoperative period could cause displacement again.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 and periprosthetic fracture of the proximal femur.A review of the medical records by a clinical consultant was unable to confirm the dislocation event: "i can confirm that the patient had a right total hip arthroplasty at some point in the past with a cementless cup and a long stem cementless femoral component.I can also confirm that the patient developed a fracture of the greater trochanter.I was able to see x-rays with the implant and the fracture in place.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of late fracture of the greater trochanter following total hip arthroplasty are multifactorial including surgical technique and patient factors including lifestyle, activity level and bmi.The cause of the initial fracture cannot be determined with certainty but trauma may have played a role.After revision the patient apparently crossed his legs and this apparently contributed to a re-fracture after the first revision.If fixation was not adequate than crossing one's leg in the initial postoperative period could cause displacement again.I would not assign any causality to the implant 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
It was reported by sales representative that patient did rthr revision on (b)(6) 2024.Had his right hip dislocated and proximal femur fracture in early february when patient crossed his legs.Been on traction treatment, and did his second rthr revision.Dr.Changed from normal trident 2 liner to constrained liner.Also, dall miles beaded wire was sued to fix the proximal femur fracture.

• Brand Name: TRIDENT 10 DEG X3 INSERT 32F
• 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: 19056341
• Report Number: 0002249697-2024-00555
• Device Sequence Number: 8167113
• Product Code: LPH
• UDI-Device Identifier: 07613327339130
• UDI-Public: 07613327339130
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024

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: 723-10-32F
• Device Lot Number: RT15W0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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: 52 YR
• Patient Sex: Male