MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM LEN; KNEE COMPONENT

Model Number	18080301
Medical Device Problem Codes	Break (1069); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
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, on (b)(6) 2012, patient had a wright medical artificial hip implanted in the right side of his body in a procedure known as a total hip arthroplasty (tha).Patient's (b)(6) 18, 2012 hip implant surgery was performed at (b)(6) hospital, (b)(6).After his initial recovery from the (b)(6) 2012, hip surgery, for several years patient's wright medical artificial hip performed as expected, and the pain and disability patient had experienced in his right hip prior to his (b)(6) 2012, hip replacement surgery had been substantially relieved.On or about (b)(6) 2020 patient was told that he suffered a broken screw holding the dynasty cup, leading to mechanical loosening of the cup and right hip pain, and that it was advisable that he undergo surgery to remove the dynasty cup and screws and replace and refix the cup and fixation screws(it is not indicated which screw was broken since patient had 3 screws implanted.Also, it has not been indicated which cup and screws were used to replace the dynasty cup and screws).While replacing the aforementioned cup on (b)(6) 2020, surgeon observed that the profemur®plus cocr modular neck was well connected to the conserve® neck sleeve, but easily came apart from the stem, and was slightly oxidized.The morse taper and the calcar modular portion were cleaned of oxidation and the original stem, neck and femoral head were impacted together resulting in solid fixation.Patient had a dislocation and further events including issues with the neck and further revision surgery.These events are captured under microport orthopedics incident group number: (b)(4).

• Brand Name: CANCELLOUS 6.5MM SELF-TAPPING BONE SCREW 2.0CM 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: 15414563
• Report Number: 3010536692-2022-00328
• Device Sequence Number: 5512374
• Product Code: HWC
• UDI-Device Identifier: M684180803011
• UDI-Public: M684180803011
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K864626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 18080301
• Device Catalogue Number: 18080301
• Device Lot Number: 1430370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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: Unknown