MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-03-56E
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding loosening & malposition involving a trident shell was reported.The event was confirmed via medical review.Method & results: -product evaluation and results: material analysis, visual, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical history, pre or postoperative records or labeled radiographs were provided for review.By report, a patient had a fall and was found to have a migrated cup and broken screw.A revision was performed (by report only) at which time the cup was found to be not well fixed.A new shell with mdm construct was placed (by report only).Event confirmation: a loose migrated acetabular component and broken screw can be confirmed.The revision surgery cannot be confirmed but would be expected.A fall cannot be confirmed.The status of the cup prior to the fall cannot be confirmed.Root cause: the root cause of the revision surgery would be a loose, migrate acetabular component and broken screw.The root cause for the cup failure cannot be ascertained." -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: it was reported that the patient was revised due to shell migration and loosening.Intraoperatively, it was noted that one of the screws was fractured.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical history, pre or postoperative records or labeled radiographs were provided for review.By report, a patient had a fall and was found to have a migrated cup and broken screw.A revision was performed (by report only) at which time the cup was found to be not well fixed.A new shell with mdm construct was placed (by report only).Event confirmation: a loose migrated acetabular component and broken screw can be confirmed.The revision surgery cannot be confirmed but would be expected.A fall cannot be confirmed.The status of the cup prior to the fall cannot be confirmed.Root cause: the root cause of the revision surgery would be a loose, migrate acetabular component and broken screw.The root cause for the cup failure cannot be ascertained." to 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 the patient's left hip was revised.Patient fell and complained of pain.X-rays showed a broken screw and possible shell migration.Intra-operatively, the shell was noted to be not well fixed.A shell, 2 screws (note: rep was unable to determine which of the 2 screws had broken), head and liner were revised to a multi-hole shell, mdm metal liner, adm/ mdm poly insert, head and sleeve.Rep confirmed there were no allegations against the revised liner or head.Rep confirmed that pictures can be sent.Otherwise, no further information will be released by the hospital or surgeon.

• Brand Name: PRIMARY TRIT HEMI CLUSTER HOLE CUP 56MM
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21941007
• Report Number: 0002249697-2025-00465
• Device Sequence Number: 8358653
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 01/31/2024
• Device Catalogue Number: 502-03-56E
• Device Lot Number: 1D12PL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American