MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-32D
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	08/13/2021
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
It has been reported "a trident psl cup and liner was inserted by a surgeon, the liner dislodged while the patient was in recovery.The patient had to go in for surgery again 5 days later (13/8) for a revision to remove the liner and replace it and insert correctly.I suspect it was not impacted correctly for the locking scallops to engage but the liner had to be revised.The cup remained".Revision and liner change.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device indicated that the device is covered in scratches and dents.Damage is consistent with attempted implantation/explantation.The outer rim of the device shows additional damage.While it is not possible to confirm, this damage appears to be consistent with misalignment of the liner with the indexing barbs on the shell.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated all 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: 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 primary 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.It was also reported that the device was implanted with a competitor femoral head.This is an off label application.Review of the ifu noticed in compatibility - insert-to-head section that "howmedica osteonics polyethylene inserts can be used with all howmedica osteonics metal or ceramic heads".It was also in warning section that " do not substitute another manufacturer's device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure".However, the trident liner was used with a competitor head".
Event or Problem Description
It has been reported "a trident psl cup and liner was inserted by a surgeon, the liner dislodged while the patient was in recovery.The patient had to go in for surgery again 5 days later (13/8) for a revision to remove the liner and replace it and insert correctly.I suspect it was not impacted correctly for the locking scallops to engage but the liner had to be revised.The cup remained".Revision and liner change.

• Brand Name: TRIDENT 10° X3 INSERT 32MM ID
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12436513
• Report Number: 0002249697-2021-01515
• Device Sequence Number: 3580615
• Product Code: LPH
• UDI-Device Identifier: 07613327039849
• UDI-Public: 07613327039849
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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: 05/12/2026
• Device Model Number: 623-10-32D
• Device Catalogue Number: 623-10-32D
• Device Lot Number: X62P54
• 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: 08/15/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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 Age: 64 YR
• Patient Sex: Female