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

Model Number	PHA04404
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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.
Additional 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
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10689448
• Report Number: 3010536692-2020-00660
• Device Sequence Number: 2949936
• Product Code: LZO
• UDI-Device Identifier: M684PHA044041
• UDI-Public: M684PHA044041
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K140043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention