MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 36MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 623-00-36D

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 03/18/2020

Event Type  Injury  

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.The following devices were also listed in this report: trident hemispherical multi; 508-11-50d;70702401.6.5 cancellous bone screw 16mm; 2030-6516-1;2p43en.6.5 cancellous bone screw 35mm; 2030-6535-1;ak1n3d.6.5 cancellous bone screw 20mm; 2030-6520-1;vt3606.Exeter v40 stem 44mm no 1;0580-1-441; g7561727.Delta v-40 ceramic head 36/+2,5;6570-0-536; 58844801.Ti sleeve for alumina head;17-0000e; l32tkv.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.

Event Description

Procedure: the patient underwent right total hip arthroplasty (b)(6) 2020.Patient was diagnosed with a dvt received anticoagulation and developed a hematoma, underwent right total hip revision (b)(6) 2020.Head and poly exchanged.Reported in cors per 8714hip (pi (b)(4)).Patient had a second debridement and irrigation on (b)(6) 2020.Head and poly exchanged again.Reported on cors per 8714hip(2) (pi (b)(4)).Patient then had infection of right hip, then underwent revision right total hip revision, all components removed on (b)(6) 2020 with insertion of off-label antibiotic loaded spacer.

• Brand Name: TRIDENT 0 DEG INSERT 36MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: alessandra chavez ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 10458099
• MDR Text Key: 204582109
• Report Number: 0002249697-2020-01742
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327025309
• UDI-Public: 07613327025309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/27/2020

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
• Device Operator: Health Professional
• Device Model Number: 623-00-36D
• Device Catalogue Number: 623-00-36D
• Device Lot Number: 274RP8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88