MAUDE Adverse Event Report: STRYKER CORP./HOWMEDICA OSTEONICS CORP. STRYKER TRIDENT PSL; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC

Model Number 626-00-46F

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2022

Event Type  Injury  

Event Description

I was in a deep squat and my hip replacement failed and slipped out.I had a bilateral hip replacement with stryker trident psl on 3/14/2018, my right hip failed about 3-5 months later cause unknown, right revision on 08/07/2019 left hip failure from a deep squat with left hip revision surgery on 05/11/2022.Fda safety report id # (b)(4).

• Brand Name: STRYKER TRIDENT PSL
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• Manufacturer (Section D): STRYKER CORP./HOWMEDICA OSTEONICS CORP.
• MDR Report Key: 14522031
• MDR Text Key: 292969194
• Report Number: MW5109954
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability; Hospitalization; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White