MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ELEVATED RIM 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	643-00-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's left hip due to infection.All implants were removed and a spacer was placed.Rep provided usage sheets from the primary and prior revision.Rep confirmed that explant pictures can be provided and that no further information will be released by the hospital or surgeon.
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.The following devices were also listed in this report: size 3 accolade ii 127 deg; cat # 6721-0330; lot # 69433801.Tridentii tritanium multi 52e; cat # 709-04-52e; lot # 72998801a.Delta uni femoral head 16/18 r36 16/18; cat # 6519-1-036; lot # 75269203.Uni adaptor sleeve v40 ti; cat # 6519-t-100; lot # 57060702.6.5mm low profile hex screw 25mm; cat # 7030-6525; lot # 3xgd.6.5mm low profile hex screw 25mm; cat # 7030-6525; lot # 432a.6.5mm low profile hex screw 15mm; cat # 7030-6515; lot # 4lcd.6.5mm low profile hex screw 25mm; cat # 7030-6525; lot # 3jl.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that a stage 1 revision was performed on the patient's left hip due to infection.All implants were removed and a spacer was placed.Rep provided usage sheets from the primary and prior revision.Rep confirmed that explant pictures can be provided and that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the devices were recently explanted.Blood and biological tissue is visible on the device surfaces.There is nothing further to note.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant -device history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: no other similar events were reported for the lot and sterile lot referenced.Conclusion: it was reported a stage 1 revision was performed on the patient due to infection.The device was not returned however photographs were provided for review.Visual inspection of the provided photographs indicated that the devices were recently explanted.Blood and biological tissue is visible on the device surfaces.There is nothing further to note.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

• Brand Name: TRIDENT X3 ELEVATED RIM 36MM 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14797190
• Report Number: 0002249697-2022-00910
• Device Sequence Number: 5778927
• Product Code: LPH
• UDI-Device Identifier: 07613327025064
• UDI-Public: 07613327025064
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 09/30/2024
• Device Model Number: 643-00-36E
• Device Catalogue Number: 643-00-36E
• Device Lot Number: 7K4XNJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 55 KG