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

Model Number	PHA00606
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be upload once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, stem migration due to stem loosening.(right hip).Resulting in a device replacement with no mpo device.
Additional Manufacturer Narrative
Updated explant date, patient and initial reporter information.

• Brand Name: STEM REVISION
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9954284
• Report Number: 3010536692-2020-00339
• Device Sequence Number: 2900677
• Product Code: LPH
• UDI-Device Identifier: M684PHA006061
• UDI-Public: M684PHA006061
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K021346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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: PHA00606
• Device Catalogue Number: PHA00606
• Device Lot Number: W112382921435416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 07/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 78