MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 52MM; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Catalog Number	540-11-52E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Implanted.
Event or Problem Description
Liner dislocation after one month of implantation.The liner was revised.Update from rep: liner dislocated from shell.

• Brand Name: TRIDENT PSL HA SOLID BACK 52MM
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7876477
• Report Number: 0002249697-2018-02871
• Device Sequence Number: 11317043
• Product Code: LPH
• UDI-Device Identifier: 04546540237835
• UDI-Public: 04546540237835
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 02/28/2023
• Device Catalogue Number: 540-11-52E
• Device Lot Number: 63313901
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 09/14/2018
• 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