MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER54E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-54E
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2022
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.Device not returned.
Event or Problem Description
As reported: "patient dislocated and was revised.Cup was repositioned and converted to an mdm.No allegations against the implants.Original usage and revision usage attached.No further information is available." spoke to rep.The head had dislocated from the liner.The elevated rim liner and femoral head were revised to a metal mdm liner, adm/ mdm poly insert, and femoral head with sleeve.The surgeon removed 2 screws from the in-situ acetabular shell, repositioned that same shell, reimplanted the original 2 screws, and added an additional screw.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
As reported: "patient dislocated and was revised.Cup was repositioned and converted to an mdm.No allegations against the implants.Original usage and revision usage attached.No further information is available." spoke to rep.The head had dislocated from the liner.The elevated rim liner and femoral head were revised to a metal mdm liner, adm/ mdm poly insert, and femoral head with sleeve.The surgeon removed 2 screws from the in-situ acetabular shell, repositioned that same shell, reimplanted the original 2 screws, and added an additional screw.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding malposition involving a trident ii shell 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 remains implanted.-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 referenced.Conclusions: it was reported that during revision procedure, a shell was explanted and subsequently reimplanted into the same patient in a different position.The malposition event could not be confirmed.The repositioning and reimplantation of a previously implanted device is considered off label per the ifu packaged with the device at the time of manufacture: "discard all damaged or mishandled implants.Never reuse an implant, even though it may appear undamaged.It may have small defects and internal stress patterns which may lead to early failure of the device.[.] the implants are a single-use device and are provided in a sterile condition for use in an operating room by a licensed orthopaedic surgeon.[.] single use devices cannot be explanted and subsequently reimplanted as the physical forces exerted by these actions may compromise the physical integrity, dimensions and/or surface finishes of the devices.Also, sterility cannot be assured for reused devices as cleaning and re-sterilization procedures have not been verified." further information such as pre- and post-operative x-rays and the primary/revision operative reports are needed to complete the investigation for confirming the event and 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.

• Brand Name: TRIDENTII TRITANIUM CLUSTER54E
• 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: brad curtis ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13945021
• Report Number: 0002249697-2022-00459
• Device Sequence Number: 17818051
• Product Code: JDI
• UDI-Device Identifier: 07613327344073
• UDI-Public: 07613327344073
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 04/13/2026
• Device Model Number: 702-04-54E
• Device Catalogue Number: 702-04-54E
• Device Lot Number: 86426501A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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 Sex: Female
• Patient Weight: 64 KG