MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN STEMMED TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Osteolysis (2377); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a right total knee arthroplasty.Subsequently, the patient has a pending revision due to loosening of the tibial component.
Additional Manufacturer Narrative
(b)(4).D10 medical devices: femoral component option size d right catalog#: 00576401452 lot#: 64469963 articular surface size cd 12 mm height "use with plate 3 catalog#: 00596403012 lot#: 64227007 all poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 64774873 customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 medical devices: femoral component option size d right catalog#: 00576401452 lot#: 64469963 articular surface size cd 12 mm height "use with plate 3 catalog#: 00596403012 lot#: 64227007 all poly patella standard cemented size 32 mm diameter 8.5 mm thickness catalog#: 00597206532 lot#: 64774873.Refobacin bc r 1x40 us catalog#: 110034355 lot#: ni.Reported event was confirmed by review of medical records.Revision operative notes confirm that patient was presented with pain and swelling and during surgery tibia was found grossly loose and tibial surface revealed medial osteolysis.Femur and patella revealed excellent fixation, left intact.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient underwent a right total knee arthroplasty.Subsequently, the patient was revised on approximately four years later due to pain, swelling, stiffness, and instability.During the revision, the tibial component was found grossly loose.Medial osteolysis was noted at the tibial surface as well.The patella and femur were found well fixed and left intact.All tibial components were revised without complication.

• Brand Name: NEXGEN STEMMED TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19548301
• Report Number: 0001822565-2024-02008
• Device Sequence Number: 11974671
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)300122(10)J6730652
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00598603702
• Device Lot Number: J6730652
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: White