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

Catalog Number	723-00-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Swelling/ Edema (4577)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding infection 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: no medical records were received for review with a clinical consultant.-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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.The following devices were also listed in this report: 709-04-54e tridentii tritanium multi 54e 11840251a 7000-5504 standard insignia collared hip stem 11313052 6570-0-036 delta v-40 ceramic head 36/-5 12683052 7030-6525 6.5mm low profile hex screw 25mm u54a 7030-6520 6.5mm low profile hex screw 20mm u34j 7030-6540 6.5mm low profile hex screw 40mm femd 7030-6515 6.5mm low profile hex screw 15mm u2ua it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Post implant on (b)(6) 2023 developed swelling and dehiscence; to ed on (b)(6) 2023 and had explant of all device on (b)(6) 2023 (right revision tha with insertion of cemented total hip/antibiotic spacer.The patient initially had a tha on (b)(6) 2023.She had wound dehiscence thereafter and developed a septic prosthetic joint.She was admitted to hf where she underwent i&d of the wound on (b)(6) and then revision of the arthroplasty with abx spacer placement (b)(6).Bcx were positive for mssa.Deep wound cx positive for mssa and enterobacter cloacae.Id was consulted and she was treated with iv ertapenem and nafcillin and discharged to regency on (b)(6) with a plan for 6 weeks of iv abx with likely oral transition thereafter.The patient developed right hip pain and increased drainage and was sent back to the hospital for reevaluation.Ct abdomen and pelvis showed at 3.2 x 1.7 x 8 cm abscess in the right iliacus muscle and gas and fluid collection within the muscular compartment of the anterolateral right thigh that appeared to be contiguous with the joint space.Blood cultures (b)(6)were 2 of 2 positive for enterococcus faecium.Repeat blood cultures (b)(6) were 1/2 positive for the same organism.Her picc line was removed (b)(6) and tip cultured with no growth.Transthoracic echo (b)(6) without evidence of endocarditis.Transesophageal echo without evidence of endocarditis.Repeat blood cultures (b)(6) without enterococcus.Repeat imaging (b)(6)showed increasing size of a subcutaneous right hip collection and psoas collection from prior imaging.She underwent ct guided aspiration of the right iliacus and right soft tissue of the hip, aspiration cultures were no growth.Infectious disease consulted for assistance with septic total hip arthroplasty and complicated bacteremia.Her blood cultures from 12/5 were 1/2 positive for candida albicans.Repeat cultures (b)(6) without growth.She was started on micafungin.The patient began to have purulent drainage from her right hip.Ortho took the patient to the or on 12/20 for i&d, found a superficial right hip abscess that did not penetrate into deep tissue and did not involve the hip joint or artificial spacer.Following surgery a wound vac was reapplied.Infectious disease made recommendations regarding antimicrobials and changed antifungal therapy to fluconazole.Id recommended continuing ertapenem and vancomycin through (b)(6) 2024, and continuing high-dose oral fluconazole through (b)(6) 2024.She was discharged to snf in good condition on (b)(6) 2023.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36E
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19265706
• Report Number: 0002249697-2024-00705
• Device Sequence Number: 7430848
• Product Code: LPH
• UDI-Device Identifier: 07613327341959
• UDI-Public: 07613327341959
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 723-00-36E
• Device Lot Number: A3853E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White