MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2021
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, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, components revised, implantation date (b)(6) 2009 and revision date (b)(6) 2021.Allegedly, the neck fractured.Additional information received on 02/26/2021: product id and lot number for femoral head, moreover confirmation that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165 (b)(6) case number: (b)(4).
Additional Manufacturer Narrative
Updated incident description.
Event or Problem Description
Allegedly, sudden sagging and cracking of the hip, he could no longer strain.Neck broke.Additional information received on 02/17/2021: exact implanting date received (b)(6) 2009, and confirmation that the stem was not revised.Additional information received on 02/18/2021: lot number for the femoral head.Additional information received on 02/25/2021: incident description, confirmation of components revised, implantation and revision date.Allegedly, the neck fractured.Additional information received on 02/26/2021: confirmation of product id and lot number for femoral head, indication that there were no deficiencies against this component.Component not revised: profemur e+ stem gr 5 product id: pha03165.Bfarm case number: (b)(4).

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11495213
• Report Number: 3010536692-2021-00157
• Device Sequence Number: 14439466
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012441
• UDI-Public: M684PHA012441
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• 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: PHA01244
• Device Catalogue Number: PHA01244
• Device Lot Number: 028549482
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/18/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2941-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85