MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number	542-11-42B
Medical Device Problem Codes	Loss of Osseointegration (2408); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
42mm trident cup was revised for loosening.Initial surgery was done 15/4/16 - surgeon reported an intra operative acetabular fracture, which did not heal and led to cup loosening.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and malposition involving a trident shell was reported.The event of loosening was not confirmed, the event of malposition was confirmed through clinician review of the provided x-ray.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: limited information.Cup position is quite vertical.Secured by two cancellous bone screws.Unclear if this was the position originally implanted or if cup migrated to this position and accepted by the surgeon.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 lot referenced.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: limited information.Cup position is quite vertical.Secured by two cancellous bone screws.Unclear if this was the position originally implanted or if cup migrated to this position and accepted by the surgeon.The event of malposition was confirmed however the exact cause of the event or the event of loosening cannot be confirmed as insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.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
42mm trident cup was revised for loosening.Initial surgery was done on (b)(6) 2016 - surgeon reported an intra operative acetabular fracture, which did not heal and led to cup loosening.

• Brand Name: TRIDENT PSL WITH PUREFIX HA
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10779484
• Report Number: 0002249697-2020-02304
• Device Sequence Number: 1125861
• Product Code: MEH
• UDI-Device Identifier: 04546540240446
• UDI-Public: 04546540240446
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AS
• PMA/510(K) Number: K983382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 09/30/2019
• Device Model Number: 542-11-42B
• Device Catalogue Number: 542-11-42B
• Device Lot Number: 49494301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 12/15/2020
• 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: 53 YR