MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L; HIP COMPONENT

Model Number PHA04418

Device Problems Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, malalignment ? socket|dislocation/subluxation.Side: l.Revision njr: (b)(6).Gender: m.Explanted: acetabular cup.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18792361
• MDR Text Key: 336397895
• Report Number: 3010536692-2024-00099
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHA04418
• Device Catalogue Number: PHA04418
• Device Lot Number: 1531141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male