MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME; HIP COMPONENT

Model Number	PHAC1224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/14/2021
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
Allegedly, left neck breakage.Basg ref.# (b)(4).
Event or Problem Description
Allegedly, left neck breakage.Basg ref.# (b)(4).Additional information received on 3/1/2021: incident description, patient information, additional components id's and lot numbers, and implant and explant date.Allegedly, the patient walks across the street on (b)(6) 2021 and reports that he fell without any external cause.Afterwards the leg no longer resilient.
Additional Manufacturer Narrative
Additional information was received on 3/1/2021 from the distributor: updated patient information, incident description and implant and explant dates.

• Brand Name: PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11371637
• Report Number: 3010536692-2021-00106
• Device Sequence Number: 19798155
• Product Code: JDL
• UDI-Device Identifier: M684PHAC12241
• UDI-Public: M684PHAC12241
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K091423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: PHAC1224
• Device Catalogue Number: PHAC1224
• Device Lot Number: 0711382765
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 95