MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 28MM ID D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-28D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/18/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Pain in left thigh and groin.
Additional Manufacturer Narrative
Additional information: device details.An event regarding pain 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 remained implanted.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate the 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: 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: cat#: 6721-0435: size 4 accolade ii 127 deg: lot#: 45671003.Cat#: 500-03-50d; primary trit hemi solidback cup 50mm; lot#: 46192501.Cat#: 6565-0-128 alumina v40-femoral head 28mm, +0mm nk; lot#: 47450204.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
No new information.

• Brand Name: TRIDENT 0 DEG X3 INSERT 28MM ID D
• 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-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22477323
• Report Number: 0002249697-2025-00684
• Device Sequence Number: 20843336
• Product Code: LPH
• UDI-Device Identifier: 07613327039382
• UDI-Public: 07613327039382
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: 04/30/2019
• Device Catalogue Number: 623-00-28D
• Device Lot Number: 47566801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2014
• 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: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown