MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM CLUSTER62G; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	702-04-60G
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: 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 was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.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 device was revised due to dissatisfaction of the shell's positioning at implantation by a different surgeon.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to a periprosthetic fracture sustained in a fall.The patient's entire hip construct (stem, shell, head, liner) was revised.Surgeon reported the reason for revising the shell was due to dissatisfaction of the shell's positioning at implantation by a different surgeon.Rep confirmed that the shell had not migrated, that there are no allegations against the revised head and liner, provided an operative report excerpt, primary usage, and revision usage, and confirmed that no further information will be released by the hospital or surgeon.The primary total hip replacement was on the left hip.
Event or Problem Description
It was reported that the patient's right hip was revised due to a periprosthetic fracture sustained in a fall.The patient's entire hip construct (stem, shell, head, liner) was revised.Surgeon reported the reason for revising the shell was due to dissatisfaction of the shell's positioning at implantation by a different surgeon.Rep confirmed that the shell had not migrated, that there are no allegations against the revised head and liner, provided an operative report excerpt, primary usage, and revision usage, and confirmed that no further information will be released by the hospital or surgeon.The primary total hip replacement was on the left hip.
Additional Manufacturer Narrative
Corrected h8 - initial use of device.

• Brand Name: TRIDENTII TRITANIUM CLUSTER62G
• 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: 11463168
• Report Number: 0002249697-2021-00425
• Device Sequence Number: 19881165
• Product Code: LPH
• UDI-Device Identifier: 07613327343755
• UDI-Public: 07613327343755
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 05/31/2024
• Device Model Number: 702-04-60G
• Device Catalogue Number: 702-04-62G
• Device Lot Number: 71576201A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 03/18/2021
• 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: 54 YR
• Patient Weight: 116