MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN 12MM HEIGHT SIZE F ARTICULAR SURFACE; PROSTHESIS, KNEE

Catalog Number	00588006012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign country: germany.Customer has indicated that the product is in process of being 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 right knee surgery on an unknown date.Subsequently, the patient fell and the rhk axle pin came loose and the patient was revised.The axle pin and inlay were replaced.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: a2; b3; b4; b5; b6; b7; d1; d2; d6; d10; e1; g1; g3; g6; h1; h2; h6.D10: unknown - unknown nexgen rhk femoral component - unknown.Unknown - unknown nexgen offset stem - unknown.Unknown - unknown nexgen nonmodular tibial component - unknown.Customer has indicated that the product is in process of being 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 further reported that the patient underwent an initial right total knee arthroplasty.Approximately 3 years post-op, the patient was revised due to loosening and disconnection of the hinge coupling.It was noted during the revision that there was no connection of the hinge to the tibial component due to the loosening of the hinge screw.The articular surface was exchanged with a new screw placed without complications.Attempts have been made and all available information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d1; d2; d4; g1; g3; g4; g6; h1; h2; h4.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d9; g1; g3; g6; h1; h2; h3; h4; h6.The event is confirmed.Visual examination of the articular surface identified signs of use and implantation in the form of gouges and wear.Evaluation of the hinge extension post found wear and damage to the threaded portion of the implant.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.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.Review of the available records identified the following: pre-revision operative notes noted a diagnosis of loosening of the coupling mechanism following implantation of a revision prosthesis right knee joint rhk zimmer.Imaging revealed detection of a disconnection of the coupling of the coupled knee prosthesis revision surgical notes noted pus and fibrin deposits found in the knee joint and samples were sent to path with no suspicion of infection.The surgeon noted loosening of the fixation hinge screw which had no connection to the tibial component.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.

• Brand Name: NEXGEN 12MM HEIGHT SIZE F ARTICULAR SURFACE
• 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: 22197468
• Report Number: 0001822565-2025-01907
• Device Sequence Number: 9227625
• Product Code: JWH
• UDI-Device Identifier: 00889024199422
• UDI-Public: (01)00889024199422(17)260118(10)64924250
• 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: 2022
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 10/06/2025

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: Lay User/Patient
• Device Expiration Date: 01/18/2026
• Device Catalogue Number: 00588006012
• Device Lot Number: 64924250
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/18/2025; 10/06/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/21/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 110 KG