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 Code	Degraded (1153)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
Event or Problem Description
The surgeon reported that he undertook a revision of a trident exeter hip.**update** the customer reported that the exeter trunnion was worn.The ceramic head was broken and the liner had wear marks.
Additional Manufacturer Narrative
An event regarding wear involving a trident liner was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: metal transfer markings observed on distal side of liner.Mar required.Visual inspection was performed as part of the material analysis report (mar), dated 18-september-2019.This inspection indicated: damage consistent with impingement against the stem was observed on rim of the insert and sleeve.Metal transfer markings and scratches were observed on the articulating surface of the alumina insert.Damage consistent with the explantation process was observed on the proximal surface of the sleeve.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: 8/13/19 brief handwritten operative note.".Post.Approach.Metalosis lymph nodes and 100 ml graphite black.Excision/lavaged.Multiple ceramic head fragments/stem/ceramic liner removed.Cement mantle intact.New components inserted." no clinical or past medical history, no comprehensive operative reports, no x-rays, no examination of explanted components, and no surgical pathology reports.While the brief, handwritten revision operative note seems to partially confirm the event description, there is insufficient data to create a report for this event.Device history review: all 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 reported lot.Conclusion the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The surgeon reported that he undertook a revision of a trident exeter hip.The customer reported that the exeter trunnion was worn.The ceramic head was broken and the liner had wear marks.

• 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: 8997522
• Report Number: 0002249697-2019-03184
• Device Sequence Number: 10854020
• Product Code: MRA
• UDI-Device Identifier: 04546540516862
• UDI-Public: 04546540516862
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/22/2019

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: 08/31/2022
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 60862703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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: 62 YR
• Patient Weight: 140