MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOWN HIP IMPLANT; HIP COMPONENT

Model Number	PHAC1204
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 metallosis.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
Updated incident description and device information.The product reported before is believed to have been implanted during the revision surgery.No further information was received for this event.
Event or Problem Description
First information receipt on (b)(6) 2020: patient's wife called (b)(6) to report that her husband had a revision surgery.New information receipt on (b)(6) 2020: allegedly, the product was dislodged but that there was metallosis.Still pending to confirm if the hip implant was manufactured by microport or another company.Apparently, at the revision they used a microport product.

• Brand Name: UNKNOWN HIP IMPLANT
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10689415
• Report Number: 3010536692-2020-00659
• Device Sequence Number: 16819257
• Product Code: LZO
• UDI-Device Identifier: M684PHAC12041
• UDI-Public: M684PHAC12041
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K091423
• 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): 12/22/2020

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: PHAC1204
• Device Catalogue Number: PHAC1204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Type of Report(Section G): Thirty-Day
• 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: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention