MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ST TIB PLT; 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); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure two years post implantation due to aseptic loosening of the tibia.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: femoral component catalog # 00596401752 lot # 64226461.Articular surface catalog # 00596405010 lot # 65054651.All poly petella catalog # 00597206535 lot # 65341213.Nxg cm flx fm/cm tb/pe/ap pt catalog # 98000250001 lot # unk.H3: the complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b4, b5, b7, d2, g1, g3, g6, h1, h2, h6.
Event or Problem Description
It was reported patient underwent a revision procedure two years post implantation due to aseptic loosening of the tibia.During the revision synovitis and osteolysis were noted.It was also noted that the tibial component was grossly loose and had completely deboned from the cement interface.Attempts to obtain additional information have been made; however, no more is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of operative notes provided.Visual evaluation of the returned device shows signs of repeated use but no bone cement remains found.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.Operative notes review indicates that the patient underwent a right total knee arthroplasty.The procedure addressed grade iv osteoarthritis, requiring removal of the anterior meniscus and acl.Trial implants demonstrated excellent alignment, balance, and tracking, and final components were placed without intraoperative complications.Further, the patient underwent a revision surgery due to aseptic loosening of the right tibial component.During the procedure, synovitis and osteolysis were observed, and the tibial component was found grossly loose and completely debonded from the cement interface.The femoral component, though well-fixed, exhibited early osteolysis posteromedially.All components except the patella were revised, and final implants were cemented with good alignment and balance.The patient later required an additional procedure, for an arthrotomy and washout due to infection.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: NEXGEN ST TIB PLT
• 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: 20683429
• Report Number: 0001822565-2024-03573
• Device Sequence Number: 15253171
• Product Code: JWH
• UDI-Device Identifier: 00889024218871
• UDI-Public: (01)00889024218871(17)280430(10)64030673
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2025

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: 00598605701
• Device Lot Number: 64030673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/23/2024
• Supplement Date Received by Manufacturer: 03/04/2025; 03/27/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/26/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male