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-36G
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Reaction (2414); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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.Device not available.
Event or Problem Description
It was reported that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.
Additional Manufacturer Narrative
Reported event: an event involving revision involving a trident insert after patient complaint of pain was reported.The event was confirmed by medical review.Method & result: dimensional, functional and material analysis not performed as the product is not returned.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant state that: provided x-ray confirms event.Need revision operative reports, office/clinical reports, serial x-rays, etc.Product history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review lot id: there have been no other events for the lot referenced.Conclusions: it was reported that patient was revised due to pain.The event is confirmed by medical review, state that provided x-ray confirms event.Need revision operative reports, office/clinical reports, serial x-rays, etc.The exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary 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 as no devices and / or insufficient information was received by stryker orthopaedics.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 that the patient's right hip was revised after patient complaint of pain.Intra- operatively, black tissue and ceramic fragments were noted, and no ceramic was inside of the alumina insert.The shell, 2 screws, alumina liner and alumina head were revised.Rep provided a primary operative report and implant sheet, pre-revision x-rays, and explant pictures.

• 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
• MDR Report Key: 8727826
• Report Number: 0002249697-2019-02354
• Device Sequence Number: 16609272
• Product Code: MRA
• UDI-Device Identifier: 04546540516862
• UDI-Public: 04546540516862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 11/30/2009
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 11054303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR