MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	502-11-48D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.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.
Event or Problem Description
Patient had primary right total hip completed on (b)(6) 2019.Patient was seen prior to revision surgery for hip dislocation and was close reduced.Patient dislocated again and was scheduled for right revision surgery on (b)(6) 2019.During dissection patient had a large hematoma that was drained and lavaged.The patient's leg was dislocated and original femoral head, cup, screws, and acetabular liner were removed.A new 50mm hemi multihole cup with a new position was inserted with three corresponding 6.5 x 25mm screws.Surgeon then requested a 36d 0° liner for trial and decided on a 36 +5 cocr v40 head.

• Brand Name: TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8707559
• Report Number: 0002249697-2019-02285
• Device Sequence Number: 2268278
• Product Code: LPH
• UDI-Device Identifier: 04546540432018
• UDI-Public: 04546540432018
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 10/31/2023
• Device Catalogue Number: 502-11-48D
• Device Lot Number: 67864703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/18/2019
• 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