MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M; HIP COMPONENT

Model Number PHA04404

Device Problems Material Fragmentation (1261); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Patient's wife called on (b)(6) 2020 to report that her husband had a revision surgery.Allegedly, the product was dislodged but that there was metalosis.Still pending to confirm if the hip implant was manufactured by microport or another company.Apparently, at the revision they used a microport product.

Manufacturer Narrative

Additional information received on (b)(6) 2020 from (b)(6), provided there is no clear evidence that implanted products are from microport.Therefore the event is not reportable.Please void the initial report.

• Brand Name: FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10689448
• MDR Text Key: 211645376
• Report Number: 3010536692-2020-00660
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: M684PHA044041
• UDI-Public: M684PHA044041
• Combination Product (y/n): N
• PMA/PMN Number: K140043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHA04404
• Device Catalogue Number: PHA04404
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Date Manufacturer Received: 09/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention