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

Model Number	623-10-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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
Patient had a left exeter trident primary hip replacement done by dr in (b)(6) 2015.Patient had a car accident and since then the hip has dislocated twice.Revision today was due to dislocation.Patient is noted by surgeon to have very lax soft tissue and he also noted she had a hip replacement done on the right side and it dislocated twice within one week post-op and required revision.Surgeon noted that the cup and stem were well positioned so the liner and head were removed and replaced with an mdm liner and new head.
Additional Manufacturer Narrative
Reported event an event regarding dislocation involving a trident liner 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 was not returned.-clinician review: the available medical records were provided to the consulting clinician for a review which was stated, "cannot confirm event, need additional information; primary and full revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components." -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient had a revision due to dislocation.The available medical information was provided to the consulting clinician for a review which was deemed insufficient to confirm the event.The event could not be confirmed nor the exact cause be determined as insufficient information was provided.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a left exeter trident primary hip replacement done by dr in (b)(6) 2015.Patient had a car accident and since then the hip has dislocated twice.Revision today was due to dislocation.Patient is noted by surgeon to have very lax soft tissue and he also noted she had a hip replacement done on the right side and it dislocated twice within one week post-op and required revision.Surgeon noted that the cup and stem were well positioned so the liner and head were removed and replaced with an mdm liner and new head.

• 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
• MDR Report Key: 9728337
• Report Number: 0002249697-2020-00358
• Device Sequence Number: 2179796
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 10/31/2019
• Device Model Number: 623-10-32E
• Device Catalogue Number: 623-10-32E
• Device Lot Number: 49564401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR