MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER52E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	702-04-52E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding malposition and infection involving an unknown trident shell was reported.The event was for subsidence was confirmed via medical review.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: "can confirm that the patient had a left total hip arthroplasty with a failed acetabular component since i was able to see an x-ray of the arthroplasty.I cannot confirm the secondary procedure of removal of the implant and insertion of a spacer since i have no documentation to support that such as operation notes or x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of acetabular failure are multifactorial including surgical technique, especially in whether or not satisfactory initial fixation was achieved after satisfactory preparation of the host bone.Patient factors including activity level, lifestyle, and bmi can contribute.In the summary stated that there was a possibility of infection and subsequently the implant was removed and a spacer inserted, that infection as a contributing cause must be included.With the information given i would not assign any causality to the implant.Stryker would have to provide information whether there was any particular failure mode identify with this particular implant.I have no personal knowledge any defects in the implant." product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised after patient complaint of pain.Surgeon reported the shell had 'spun out' and infection was also suspected.A review of the provided medical records by a clinical consultant indicated: "can confirm that the patient had a left total hip arthroplasty with a failed acetabular component since i was able to see an x-ray of the arthroplasty.I cannot confirm the secondary procedure of removal of the implant and insertion of a spacer since i have no documentation to support that such as operation notes or x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of acetabular failure are multifactorial including surgical technique, especially in whether or not satisfactory initial fixation was achieved after satisfactory preparation of the host bone.Patient factors including activity level, lifestyle, and bmi can contribute.In the summary stated that there was a possibility of infection and subsequently the implant was removed and a spacer inserted, that infection as a contributing cause must be included.With the information given i would not assign any causality to the implant.Stryker would have to provide information whether there was any particular failure mode identify with this particular implant.I have no personal knowledge any defects in the implant." further information such as device identification details, return of the device, 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: unknown 30mm screw; cat/lot# unknown; unknown e mdm metal liner; cat/lot# unknown; unknown e adm/ mdm poly insert; cat/lot# unknown; unknown 28 +0 biolox head; cat/lot# unknown; size 6 accolade ii; cat# 6720-0635; lot# 6638402.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of pain.Surgeon reported the shell had 'spun out' and infection was also suspected.The patient's hip construct was removed and a spacer was placed.Rep provided x-rays and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Corrected data: manufacturing site for devices (g1).An event regarding malposition and infection involving a trident ii shell was reported.The event was for subsidence was confirmed via medical review.Method & results: product evaluation and results: visual inspection of the returned device indicated bone growth on the outer surface of the shell with a hip screw assembled to it, as well as the mdm liner.Damage is consistent with time spent implanted and damage consistent with explantation.Clinician review: a review of the provided medical records by a clinical consultant indicated: "can confirm that the patient had a left total hip arthroplasty with a failed acetabular component since i was able to see an x-ray of the arthroplasty.I cannot confirm the secondary procedure of removal of the implant and insertion of a spacer since i have no documentation to support that such as operation notes or xrays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of acetabular failure are multifactorial including surgical technique, especially in whether or not satisfactory initial fixation was achieved after satisfactory preparation of the host bone.Patient factors including activity level, lifestyle, and bmi can contribute.In the summary stated that there was a possibility of infection and subsequently the implant was removed and a spacer inserted, that infection as a contributing cause must be included.With the information given i would not assign any causality to the implant.Stryker would have to provide information whether there was any particular failure mode identify with this particular implant.I have no personal knowledge any defects in the implant." 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 after patient complaint of pain.Surgeon reported the shell had 'spun out' and infection was also suspected.A review of the provided medical records by a clinical consultant indicated: "can confirm that the patient had a left total hip arthroplasty with a failed acetabular component since i was able to see an x-ray of the arthroplasty.I cannot confirm the secondary procedure of removal of the implant and insertion of a spacer since i have no documentation to support that such as operation notes or xrays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of acetabular failure are multifactorial including surgical technique, especially in whether or not satisfactory initial fixation was achieved after satisfactory preparation of the host bone.Patient factors including activity level, lifestyle, and bmi can contribute.In the summary stated that there was a possibility of infection and subsequently the implant was removed and a spacer inserted, that infection as a contributing cause must be included.With the information given i would not assign any causality to the implant.Stryker would have to provide information whether there was any particular failure mode identify with this particular implant.I have no personal knowledge any defects in the implant." visual inspection of the returned device indicated bone growth on the outer surface of the shell with a hip screw assembled to it, as well as the mdm liner.Damage is consistent with time spent implanted and damage consistent with explantation.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: unknown 30mm screw; cat/lot# unknown.Unknown e mdm metal liner; cat/lot# unknown.Restoration adm x3 ins 28/48; cat# 1236-2-848; lot# unknown.Unknown 28 +0 biolox head; cat/lot# unknown.Size 6 accolade ii; cat# 6720-0635; lot# 86638402.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of pain.Surgeon reported the shell had 'spun out' and infection was also suspected.The patient's hip construct was removed and a spacer was placed.Rep provided x-rays and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENTII TRITANIUM CLUSTER52E
• 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 NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20280958
• Report Number: 0002249697-2024-01313
• Device Sequence Number: 20723858
• Product Code: LPH
• UDI-Device Identifier: 07613327343915
• UDI-Public: 07613327343915
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/10/2025

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 702-04-52E
• Device Lot Number: 84771901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 103 KG