MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-CORK TRIDENT PSL HA CLUSTER 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-48D
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/28/2020
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.Device not available.
Event or Problem Description
Doctor reports patient at status post left anterior hip replacement done approximately 2 weeks ago may have fallen and now has an acetabular fracture and the cup has shifted as well as protruded through the medial wall.Doctor requested to revise the acetabulum.The cup was carefully removed and then preparation of the acetabulum was performed to implant a tritanium revision cup.After bone grafting the medial wall the cup was implanted and multiple screws were used to augment it¿s fixation.Satisfied with the cup a liner was impacted.It was then noticed the accolade cemented stem was loose.Dr decided to re cement a new stem into the existing mantle.A trial head was used to check stability.A new head was implanted and the surgical site was closed.The surgery was performed without incident.No further information is available due to emr password secured.

• Brand Name: TRIDENT PSL HA CLUSTER 48MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; IE NA
• MDR Report Key: 10446104
• Report Number: 0002249697-2020-01697
• Device Sequence Number: 2795717
• Product Code: LPH
• UDI-Device Identifier: 07613327037180
• UDI-Public: 07613327037180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: 10/20/2024
• Device Model Number: 542-11-48D
• Device Catalogue Number: 542-11-48D
• Device Lot Number: 72717502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 08/24/2020
• 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