MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR Z STEM; HIP COMPONENT

Model Number	PHA00236
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
Event or Problem Description
Allegedly, patient was revised due to stem aseptic loosening.Items not revised: cotyle "anca" avec trous a/revet.Hap 56, catalog # ppr67256, lot # u0362491, qty 1.Insert ceram "anca fit?" 28/44 56-58/28 al2.O3 biolox forte, catalog # ppr67512, lot # t12139243, qty 1.

• Brand Name: PROFEMUR Z STEM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10213080
• Report Number: 3010536692-2020-00458
• Device Sequence Number: 2272789
• Product Code: LPH
• UDI-Device Identifier: M684PHA002361
• UDI-Public: M684PHA002361
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2020

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: Health Professional
• Device Model Number: PHA00236
• Device Catalogue Number: PHA00236
• Device Lot Number: U0470645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 06/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 36 YR