MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-58G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had previously had his primary hip replacement revised, a standard trident insert and 32mm femoral head were explanted and a trident constrained insert and 28mm vitallium femoral head were implanted.Reason for this revision yesterday was that the constrained insert had dislocated.The patient reported to hospital as the hip prosthesis in-situ had dislocated.The whole trident constrained insert had dislocated from the trident shell, and then somehow the bipolar head had dislocated from the insert that it had been pre-assembled in.The bipolar head still had the femoral head within it, which itself was still intact on the accolade stem trunnion.
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.H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
An event regarding disassociation involving a trident shell was reported.The event was confirmed through 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: the hip is dislocated.There is a dislodged constrained liner from the shell as well as dislocation of the bipolar component from the constrained liner.Conclusion/assessment: by report a patient underwent a revision hip surgery as well as an abductor transfer.The exact components were unclear, but an mdm may have been implanted.It is unclear what transpired with this construct, but the patient was implanted with a constrained liner.This constrained liner went on to fail with both a dislocation of the bipolar head from the constrained liner and dislodgement of the constrained liner from the trident shell.No preoperative or postoperative records were provided for review.Event confirmation: a dislocation of a constrained head and dislodgement of a constrained liner can be confirmed by x-ray.No other portions of the report can be confirmed.Root cause: the root cause of the failure of the constrained construct cannot be determined from the materials provided.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.Device history review: review of the device history records indicate 24 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.Conclusion: it was reported that the patient was revised due to disassociation of the liner from the shell.A review of the provided medical records by a clinical consultant indicated: the hip is dislocated.There is a dislodged constrained liner from the shell as well as dislocation of the bipolar component from the constrained liner.Conclusion/assessment: by report a patient underwent a revision hip surgery as well as an abductor transfer.The exact components were unclear, but an mdm may have been implanted.It is unclear what transpired with this construct, but the patient was implanted with a constrained liner.This constrained liner went on to fail with both a dislocation of the bipolar head from the constrained liner and dislodgement of the constrained liner from the trident shell.No preoperative or postoperative records were provided for review.Event confirmation: a dislocation of a constrained head and dislodgement of a constrained liner can be confirmed by x-ray.No other portions of the report can be confirmed.Root cause: the root cause of the failure of the constrained construct cannot be determined from the materials provided.Certification: i certify that i have completed the medical risk assessment form to the best of my abilities as a healthcare professional and that my opinions reflect my personal and independent medical judgment and analysis.The exact cause of the event could not be determined because insufficient information was provided.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The patient had previously had his primary hip replacement revised, a standard trident insert and 32mm femoral head were explanted and a trident constrained insert and 28mm vitallium femoral head were implanted.Reason for this revision yesterday was that the constrained insert had dislocated.The patient reported to hospital as the hip prosthesis in-situ had dislocated.The whole trident constrained insert had dislocated from the trident shell, and then somehow the bipolar head had dislocated from the insert that it had been pre-assembled in.The bipolar head still had the femoral head within it, which itself was still intact on the accolade stem trunnion.

• Brand Name: TRIDENT PSL HA CLUSTER 58MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16930319
• Report Number: 0002249697-2023-00524
• Device Sequence Number: 12496331
• Product Code: LPH
• UDI-Device Identifier: 07613327037319
• UDI-Public: 07613327037319
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

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: 04/30/2022
• Device Model Number: 542-11-58G
• Device Catalogue Number: 542-11-58G
• Device Lot Number: 58694202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2017
• 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: 65 YR
• Patient Sex: Male