MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PS INSRT IMPL SZ 6 RIGHT 12MM IMPLANT PARTNERS?; KNEE COMPONENT

Model Number	EPI6412RWD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
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, patient was revised due to disassociation.
Additional Manufacturer Narrative
Section b.5 :additional information in description / section d.4: lot # added.
Event or Problem Description
Allegedly, patient was revised due to disassociation.Additional information received from patient records 23 nov.2021: updating product/lot information.Additional investigation to be performed.

• Brand Name: PS INSRT IMPL SZ 6 RIGHT 12MM IMPLANT PARTNERS?
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12101094
• Report Number: 3010536692-2021-00349
• Device Sequence Number: 17087574
• Product Code: HRY
• UDI-Device Identifier: M684EPI6412RWD1
• UDI-Public: M684EPI6412RWD1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2022

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: EPI6412RWD
• Device Catalogue Number: EPI6412RWD
• Device Lot Number: 15188691579834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 06/08/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/26/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male