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

Catalog Number	702-04-56F
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	11/20/2024
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.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.
Event or Problem Description
Subject presented to clinic on (b)(6) 24 with right hip pain.X-rays and ct scans were ordered.Subject returned to clinic (b)(6) 2024, where the ct was noted to show that the cup was retroverted and there was also lucency around the screw.The bone scan showed increased activity in the acetabulum.Infective markers were negative.Findings indicated aseptic loosening of the right acetabular component.Subject requires revision surgery which may also require extended trochanteric osteotomy and removal of the stem given the bone loss associated with the acetabular removal.Revision surgery is scheduled for (b)(6) 2025.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a trident ii shell was reported.The event was confirmed via clinician review.Method & results: device 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 medical records by a clinical consultant indicated: 'conclusion/assessment: no sequential medical records were provided for review.The preoperative assessment was not provided for review.By report a patient was having pain 2 years post tha.The work-up apparently indicated loosening of the cup.A revision was performed.The cup was found to be loose.The stem was removed for exposure purposes.A new shell was placed with an acetabular augment due to bone loss posterior and medial.The postoperative course and postoperative x-rays were not provided for review.Event confirmation: a revision surgery and loose acetabular component can be confirmed based on an operative report.The patient¿s preoperative symptoms, and preoperative workup findings cannot be confirmed without additional medical records.Root cause: the root cause of the revision was loosening of the acetabular component.The root cause of the loosening cannot be ascertained.' device 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 reported lot.Conclusion: it was reported that 'subject presented to clinic on 10/30/24 with right hip pain.X-rays and ct scans were ordered.Subject returned to clinic 11/20/24, where the ct was noted to show that the cup was retroverted and there was also lucency around the screw.The bone scan showed increased activity in the acetabulum.Infective markers were negative.Findings indicated aseptic loosening of the right acetabular component.Subject requires revision surgery which may also require extended trochanteric osteotomy and removal of the stem given the bone loss associated with the acetabular removal.Revision surgery is scheduled for (b)(6) 2025.' a review of medical records by a clinical consultant indicated: "a review of medical records by a clinical consultant indicated: ' a revision surgery and loose acetabular component can be confirmed based on an operative report.The patient¿s preoperative symptoms, and preoperative workup findings cannot be confirmed without additional medical records.' 'the root cause of the revision was loosening of the acetabular component.The root cause of the loosening cannot be ascertained.' 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
Subject presented to clinic on (b)(6) 2024 with right hip pain.X-rays and ct scans were ordered.Subject returned to clinic (b)(6) 2024, where the ct was noted to show that the cup was retroverted and there was also lucency around the screw.The bone scan showed increased activity in the acetabulum.Infective markers were negative.Findings indicated aseptic loosening of the right acetabular component.Subject requires revision surgery which may also require extended trochanteric osteotomy and removal of the stem given the bone loss associated with the acetabular removal.Revision surgery is scheduled for (b)(6) 2025.

• 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: 21080397
• Report Number: 0002249697-2025-00001
• Device Sequence Number: 8428018
• Product Code: LPH
• UDI-Device Identifier: 07613327344004
• UDI-Public: 07613327344004
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 702-04-56F
• Device Lot Number: 96196101A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 280 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White