MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577); Insufficient Information (4580); Bursitis (4832); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2024-00401, 3007963827-2024-00028, 0002648920-2024-00031.D10- medical product articular surface size ef 12 mm height item# 00596403212 lot# 64066055 femoral component option size e right item# 00596401552 lot# 64241488 all poly petella standard cemented size 32 mm diameter 8.5 mm thickness item# 00597206532 lot# 64129894 g2- united kingdom no product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.The complaint is not confirmed.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 was revised approximately four years and six weeks post implantation due to unknown reasons.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.
Event or Problem Description
It was reported that approximately four years and six weeks post implantation a patient was revised due to pain, limited rom, swelling, osteolysis, and progressive loosening of the tibial baseplate.Operative notes reported aseptic loosening, loose tibial component de-bonded from tibial component, massive synovitis, poly wear, backside wear and excoriation of tibial try, and large contained medical femoral condyle cyst.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, g1, g3, g6, h1, h2, h3, h6, and h11.Corrected: h4.Medical records provided and reviewed state that the patient underwent a primary right total knee arthroplasty on (b)(6) 2019 using zimmer biomet implants and competitor bone cement.Following the procedure, the patient developed pain, swelling, limited range of motion, joint effusion, synovitis, prepatellar bursitis, and progressive loosening of the tibial baseplate.Radiographic findings later confirmed aseptic loosening, and multiple clinical visits documented persistent symptoms including clunking sensation, locking, and increasing discomfort.A revision surgery was performed on (b)(6) 2023.Intraoperative findings included a loose tibial component with debonded cement, massive synovitis, polyethylene wear, backside wear and excoriation of tibial tray, large medial femoral condyle cyst.All components except the patellar implant were explanted and replaced with competitor products.Post-revision notes describe ongoing but improving symptoms consistent with expected inflammatory response.A definitive root cause cannot be determined.However, during the investigation it was identified that competitor devices were implanted with the retained zimmer biomet "all poly petella standard cemented size 32 mm diameter 8.5 mm thickness".Zimmer biomet has not confirmed the compatibility for this combination of devices.This is known as off-label use.Please note that per the ifu, 87-6203-614-99 en rev.E, it states "do not use: the components of the nexgen® all-polyethylene patella system with components of any other system or manufacturer, unless authorized by zimmer biomet".Complaint is confirmed based on medical records provided.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
No further event information available at the time of this report.

• Brand Name: STEMMED NONAUGMENTABLE TIBIAL COMPONENT OPTION CR/PS/LPS SIZE 4
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18659110
• Report Number: 0002648920-2024-00032
• Device Sequence Number: 8213114
• Product Code: JWH
• UDI-Device Identifier: 00889024218840
• UDI-Public: (01)00889024218840(17)281031(10)64210105
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

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: 64210105
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 03/14/2025; 08/14/2025
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/08/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 92 KG