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

Catalog Number	625-0T-32F
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Fractured and worn ceramic liner.Worn ceramic head.Replaced liner and head and sleeve.Replacement was a x3 poly liner and ceramic head after in-depth discussion regarding bearing surfaces and possibility of ceramic fragments causing third body wear of a poly liner.Was climbing ladder to access tree approx 2/12 prior to revision surgery.Only noticed increase in pain, hence presenting 2 months post event.
Additional Manufacturer Narrative
An event regarding crack/fracture and wear involving a trident liner was reported.The event of crack/fracture was confirmed by provided photograph; the event of wear was not confirmed.A hip dislocation event was identified and confirmed by medical review.Method & results product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:the trident ceramic liner including the metal part was explanted with blood and tissue on it.About half of the ceramic liner rim was fragmented and about one quarter of the metal part rim was fractured/ damaged.There are black/dark stains in the ceramic liner inside surface.The ceramic femoral head was also explanted with blood on it.About half surface of the femoral head is covered with black stain.No obvious worn or other damage can be seen on the femoral head.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray confirms dislocated left hip.Need operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event of crack/fracture was confirmed by provided photograph; the event of wear was not confirmed.The medical review confirmed the hip dislocation.The exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Fractured and worn ceramic liner.Worn ceramic head.Replaced liner and head and sleeve.Replacement was a x3 poly liner and ceramic head after in-depth discussion regarding bearing surfaces and possibility of ceramic fragments causing third body wear of a poly liner.Was climbing ladder to access tree approx (b)(6) 2012 prior to revision surgery.Only noticed increase in pain, hence presenting 2 months post event.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8804527
• Report Number: 0002249697-2019-02606
• Device Sequence Number: 13533060
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/18/2019

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: 01/31/2009
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: U7882004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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: 71 YR
• Patient Weight: 80