MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NKII POROUS COATED STEMMED TIBIAL BASEPLATE LEFT SIZE 2; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Ambulation or Postural Difficulties (2544); Subluxation (4525); Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00587806535 - nexgena complete knee solution, trabecular metala standard primary patella - 64975768.00541201701 - gender solutions male (gsm) femoral component porous size 4, left - 64693603.00542801116 - articular surface ultracongruent 'size 1 2 left 16 mm height' - 64284491.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial knee surgery.Approximately 2.5 years later, the patient was revised due to a tibial plate fracture.The rep noted that the patient had a bone cyst on his tibial plateau.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10: unknown - unknown patella - unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial left total knee arthroplasty.Approximately 2.5 years post-op, the patient was revised due to an implant fracture, pain, ambulation difficulties after playing softball and jumping up to catch a ball.During the revision, the surgeon noted disassociation, black synovial tissue, and a loose and fractured tibial baseplate, subluxation, and large medial plateau tibia bone cyst.All components were exchanged without complications except for patella which was well fixed and remained implanted.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.Review of complaint history found no additional related issues for this item and the reported part and lot combination.Medical records were provided and reviewed by a health care professional.Records noted a tibial bone defect to be significant with large medial tibial plateau cyst with loose and broken tibial baseplate.Patella and femur well fixed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left total knee arthroplasty with fractured medial tibial component with associated subsidence.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NKII POROUS COATED STEMMED TIBIAL BASEPLATE LEFT SIZE 2
• 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: 18958267
• Report Number: 0001822565-2024-01003
• Device Sequence Number: 13102562
• Product Code: JWH
• UDI-Device Identifier: 00889024251724
• UDI-Public: (01)00889024251724(17)310531(10)65087345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 08/26/2024

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: 621200220
• Device Lot Number: 65087345
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 08/23/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/04/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.; SEE H10.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 148 KG