MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10 DEG X3 INSERT 36E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	723-10-36E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: primary tritanium hemi cluster hole cup 54mm; cat # 502-03-54e; lot # at26j3.6.5 cancellous bone screw 25mm; cat # 2030-6525-1; lot # my6kt5.Size 4 accolade ii 127 deg; cat # 6721-0435; lot # 92019303.Delta v-40 ceramic head 36/0; cat # 6570-0-136; lot # 91060505.6.5 cancellous bone screw 35mm; cat # 2030-6535-1; lot # y507wm.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as product was not returned.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 or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.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 revision 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.H3 other text : not available.
Event or Problem Description
Revision hip due to infection.Initial surgery performed on (b)(6) 2022.First stage revision on (b)(6) 2023 - replaced with 44 #0 exeter stem, 36mm +0mm head, and 52od 36mmid rimfit cup.

• Brand Name: TRIDENT 10 DEG X3 INSERT 36E
• 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: 17322324
• Report Number: 0002249697-2023-00773
• Device Sequence Number: 5641840
• Product Code: LPH
• UDI-Device Identifier: 07613327339611
• UDI-Public: 07613327339611
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Model Number: 723-10-36E
• Device Catalogue Number: 723-10-36E
• Device Lot Number: 1V6129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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: 58 YR
• Patient Sex: Female