MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	625-0T-28D
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "patient allegedly felt some squeaking and mild grinding of her hip implant.She claims that her hip gave out while stepping out of the shower.Patient was being revised for possible fractured ceramic head.".
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.H3 other text : device not returned to the manufacturer.
Additional Manufacturer Narrative
Correction: investigation conclusion reveals that this reported device is not a suspected cause or contributor to the patient's experience and considered concomitant.An event regarding crack/fracture of a ceramic head involving a trident liner was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.Visual inspection of the returned devices indicated that the ceramic head had fractured into many pieces.The damage observed to the bearing surface of the returned trident liner is consistent with contact with the femoral component as well as debris from the fractured ceramic head.As the fracture of the ceramic head necessitated revision of the liner as well, the liner is considered concomitant.A full investigation is completed on the ceramic head within the same pi.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that "patient allegedly felt some squeaking and mild grinding of her hip implant.She claims that her hip gave out while stepping out of the shower.Patient was being revised for possible fractured ceramic head.".

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19070220
• Report Number: 0002249697-2024-00567
• Device Sequence Number: 15166983
• Product Code: MRA
• UDI-Device Identifier: 04546540516831
• UDI-Public: 04546540516831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 11/30/2018
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: 46089802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 08/10/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2013
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 100 KG