MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM SOLID 60G; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Catalog Number	700-04-60G
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Painful hip, replaced the mdm insert / biolox head.
Additional Manufacturer Narrative
The following devices were also listed in this report: delta c-taper head 28mm +0; cat# 18-2800; lot# 73581301.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Additional Manufacturer Narrative
Reported event; an event regarding malposition involving a trident ii shell was reported.The event was confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted.-clinician review: a review of medical records with a clinical consultant indicated "the implant sheet provided documents components consistent with a revision surgery.Revision surgery is further documented by the intraoperative photograph of the mdm liner and ceramic head.X-rays show a press fit tha.The cup is in a vertical position.No other mechanical complication is identified.The root cause of this painful hip requiring revision cannot be determined from the documentation provided.' -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 referenced.Conclusions: a review of medical records with a clinical consultant indicated "the implant sheet provided documents components consistent with a revision surgery.Revision surgery is further documented by the intraoperative photograph of the mdm liner and ceramic head.X-rays show a press fit tha.The cup is in a vertical position.No other mechanical complication is identified.The root cause of this painful hip requiring revision cannot be determined from the documentation provided.' no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Painful hip, replaced the mdm insert / biolox head.

• Brand Name: TRIDENTII TRITANIUM SOLID 60G
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20846649
• Report Number: 0002249697-2024-01670
• Device Sequence Number: 19775768
• Product Code: LPH
• UDI-Device Identifier: 07613327343885
• UDI-Public: 07613327343885
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 08/31/2019
• Device Catalogue Number: 700-04-60G
• Device Lot Number: 73669701A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2019
• 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: Male