MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE EF 14 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	00596403214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Inflammation (1932); Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Medical device site infection (4845)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).B3: onset of patient symptoms is reported to have occurred in (b)(6) 2025.D10: stemmed tibial component precoat size 3: catalog#00598003701, lot#j6828726; lps flex femoral component size e left: catalog#00596801551, lot#65117559.G2: foreign - event occurred in germany.Visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.The product remains implanted.Device history record was reviewed and no discrepancies related to the reported event were found.The reported products were reviewed for compatibility and it was determined that the femoral implant and articular surface are not compatible.Regarding the reported infection, the root cause is considered not device related.All products manufactured followed appropriate standards, and the reported infection occurred > 90 days; therefore, implanted products are not identified as the source or contributing to the reported infection.Root cause was unable to be determined regarding the additional patient complications beyond infection; however, it was identified that the patient had non-compatible devices in situ.The implanted femoral and articular surface device combination is not approved/cleared for use and is not a legally marketed combination per the device instructions for use.The reported event was unable to be confirmed.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
It was reported that a patient underwent a total knee procedure.Approximately one (1) year and four (4) months post-implantation, the patient began to experience pain, swelling, and inflammation.Diagnostic imaging and punctures revealed fluid accumulation due to a ruptured baker's cyst however no evidence of loosening or other complications were present.The patient then began to experience difficulty ambulating with further increased pain and swelling after significant activity.Approximately ten (10) months post symptom onset, an additional diagnostic sample revealed infection in the implanted joint.Subsequent intervention as a result of the confirmed infection has not been reported and the devices remain implanted.All available information has been provided.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE EF 14 MM HEIGHT
• 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: 25693090
• Report Number: 0001822565-2026-02431
• Device Sequence Number: 13179142
• Product Code: JWH
• UDI-Device Identifier: 00889024634947
• UDI-Public: (01)00889024634947(17)280613(10)66082241
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: Lay User/Patient
• Device Catalogue Number: 00596403214
• Device Lot Number: 66082241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown