MAUDE Adverse Event Report: APEX SURGICAL, LLC. APEX GENERATION ONE 200210 D09 TOTAL HIP COMPONENTS SHORT 40; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, +ADDITIVE, POROUS, UN

Model Number 200210 D09

Device Problem Fracture (1260)

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

Event Date 02/03/2023

Event Type  Injury  

Event Description

Patient had an apex 200210 d09 short 40 total hip approx 20 years ago.On (b)(6) 2023 while in shower, felt pop and unable to put weight on leg.Emsa (emergency medical services appropriation) called and brought to ed (emergency dept) where x-ray revealed a "hardware failure with fracture of the femoral component of right total hip arthroplasty".

• Brand Name: APEX GENERATION ONE 200210 D09 TOTAL HIP COMPONENTS SHORT 40
• Type of Device: HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, +ADDITIVE, POROUS, UN
• Manufacturer (Section D): APEX SURGICAL, LLC.
• MDR Report Key: 16398153
• MDR Text Key: 309880460
• Report Number: MW5115010
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200210 D09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White