MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-56F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "x rays demonstrate failed acetabular prosthesis with acetabular fracture.No mechanism of injury was described by patient." rep provided an x-ray, explant pictures, and revision usage.A shell, mdm metal liner, adm/ mdm poly insert, ceramic head, and 2 screws were revised.Rep confirmed that there are no allegations against the revised liner construct or femoral head.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
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.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.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture of the patients acetabulum involving a trident shell was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -device evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted shell.Blood and ingrowth is visible on the shell.The shell appears unremarkable.-clinician review: a review of the provided medical records by a clinical consultant indicated: as i described above this inquiry presents case of total hip arthroplasty failure secondary to acetabular protrusion into the pelvis with subsequent fracture of the acetabulum with possible pelvic discontinuity.Based on the information provided i cannot determine a root cause for this event.If the patient sustained significant blunt force trauma, a well fixed and well-placed acetabular implant could indeed fracture through the acetabular wall into the pelvis.If the acetabular component was placed in a protruded or medial position with a very thin wall then lighter trauma could have contributed to this.In my opinion this would not be the result of simple activities of daily living.In my opinion the product itself did not factor in to causing this event.-device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant indicated: as i described above this inquiry presents case of total hip arthroplasty failure secondary to acetabular protrusion into the pelvis with subsequent fracture of the acetabulum with possible pelvic discontinuity.Based on the information provided i cannot determine a root cause for this event.If the patient sustained significant blunt force trauma, a well fixed and well-placed acetabular implant could indeed fracture through the acetabular wall into the pelvis.If the acetabular component was placed in a protruded or medial position with a very thin wall then lighter trauma could have contributed to this.In my opinion this would not be the result of simple activities of daily living.In my opinion the product itself did not factor in to causing this event.
Event or Problem Description
As reported: "x rays demonstrate failed acetabular prosthesis with acetabular fracture.No mechanism of injury was described by patient." rep provided an x-ray, explant pictures, and revision usage.A shell, mdm metal liner, adm/ mdm poly insert, ceramic head, and 2 screws were revised.Rep confirmed that there are no allegations against the revised liner construct or femoral head.No further information will be released by the hospital or surgeon.

• Brand Name: TRIDENTII TRITANIUM CLUSTER56F
• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14748368
• Report Number: 0002249697-2022-00866
• Device Sequence Number: 4706019
• Product Code: LPH
• UDI-Device Identifier: 07613327344004
• UDI-Public: 07613327344004
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 06/30/2023
• Device Model Number: 702-04-56F
• Device Catalogue Number: 702-04-56F
• Device Lot Number: 66138201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2018
• 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: 56 YR
• Patient Sex: Male