MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN; KNEE COMPONENT

Model Number	18080303
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to adverse soft tissue reaction to particulate debris components not revised: product:profemur® l hip stem size 5 ha coated product id: pha05510 lot#:1674917 qty:1 product:profemur® neck a/r 8dglong cobalt chrome product id: phac1234 lot#:1830376.Qty:1.Revision njr number: 4840985.Side:l.Primary asa: p2 - mild disease not incapacitating.Additional information on 07/05/2022: post op x-ray indicated there was possibly a need for revision.The revision was conducted 8 (eight) days later.According to the x-ray the procotyl l was spin out, but there are not copies of this x-ray.We received two new parts which belong to screws.

• Brand Name: CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN
• 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: 15324945
• Report Number: 3010536692-2022-00305
• Device Sequence Number: 5863800
• Product Code: HWC
• UDI-Device Identifier: M684180803031
• UDI-Public: M684180803031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: Health Professional
• Device Model Number: 18080303
• Device Catalogue Number: 18080303
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/30/2022
• 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 Age: 59 YR
• Patient Sex: Male