MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN ARTICULAR SURFACE SIZE BLUE/C-H 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number	00595205010
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577); Hemarthrosis (4889)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: unknown tibial tray: catalog#ni, lot#ni; unknown femoral component: catalog#ni, lot#ni.G2: foreign: germany.Diligence is in progress to determine whether the product is available for evaluation by the manufacturer.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Approximately four (4) weeks post-implantation, the patient began to experience recurrent, atraumatic hemarthrosis.Subsequently, seven (7) months post-implantation, the patient underwent revision surgery.The articular surface was found to have clear signs of abrasion and was replaced without complication.The tibial and femoral components remain implanted.Diligence is in progress for this event; to date no additional information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d10; g3; h2; h3; h4; h6; h11.D10: medical product: stemmed tibial component precoat size 8: catalog#00598005702, lot#j7439238; femoral component precoat size g right: catalog#00595001702, lot#66723010.Visual examination of the returned product exhibits signs of implantation with a ding in the dovetail slot.There is gouging, wear, and pitting noted on the proximal articulating surface along with damage and abrasions on the implants distal surface.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: swelling, pain and gait unsteadiness in the right knee for the first time after a 1-hour beach walk on vacation in seven months post-implantation; since then recurrent swelling and tightness.Revision operative report: dx: non traumatic hemarthrosis, leading to restrictive movement.Upon entering joint, plenty of hemarthrosis encountered and emptied.No relevant source of bleeding found.Poly exchange.No complications noted.Regarding the implant wear and reported pain, swelling, and range of motion limitations, root cause was unable to be determined.Regarding the reported hemarthrosis, investigation results concluded that the root cause of the reported event was determined to be not related to the device and no device problem was found.Reported event was confirmed by review of provided medical records and complaint sample evaluation.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 at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: a1; a2; a4; b4; b5; b7; d9; g3; h2; h6; h11.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial right total knee arthroplasty.Approximately four (4) weeks post-implantation, the patient began to experience recurrent, atraumatic hemarthrosis, pain, swelling, and loss of range of motion.Subsequently, seven (7) months post-implantation, the patient underwent revision surgery.The articular surface was found to have clear signs of abrasion and was replaced without complication.The tibial and femoral components remain implanted.Diligence is complete and all available information has been provided.

• Brand Name: NEXGEN ARTICULAR SURFACE SIZE BLUE/C-H 10 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: 22783909
• Report Number: 0001822565-2025-02894
• Device Sequence Number: 18206847
• Product Code: JWH
• UDI-Device Identifier: 00889024208063
• UDI-Public: (01)00889024208063(17)280428(10)66014395
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 00595205010
• Device Lot Number: 66014395
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 10/23/2025; 01/13/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 11/11/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2023
• 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.; SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 100 KG