MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. TIB BASE COCR NON POR SZ 6 IMPLANT PARTNERS?; KNEE COMPONENT

Model Number	KTCCNP40WD
Medical Device Problem Code	Loss of Osseointegration (2408)
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, customer experience representative received a call from a patient's relative inquiring about some implant partners parts that have been recalled and she wanted to know if the items used on her brother's surgery some time ago should be recalled and what the process would be.She mentioned that one of the lot numbers on her brother's medical records is 1852119, but she says there are many items on the records and she would like to check them all.A follow-up call regarding this case was received on (b)(6) 2022: the original conversations never mentioned complications and only requested if any products had been recalled.However, on this follow-up phone call, the patient indicated loosening of implants.No further details have been provided.It has not been indicated if the devices have been revised yet.

• Brand Name: TIB BASE COCR NON POR SZ 6 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: 15053247
• Report Number: 3010536692-2022-00255
• Device Sequence Number: 17339521
• Product Code: HRY
• UDI-Device Identifier: M684KTCCNP40WD1
• UDI-Public: M684KTCCNP40WD1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K960617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/05/2022

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: KTCCNP40WD
• Device Catalogue Number: KTCCNP40WD
• Device Lot Number: 1857005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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